{
  "name": "Peptide Care Index FDA approval reference",
  "version": "2026-10-14",
  "jurisdiction": "United States",
  "scope": "Selected peptide and modified-peptide ingredients with FDA-approved product examples; four larger protein examples separate. Not a comprehensive count of all FDA-approved peptides.",
  "date_checked": "2026-10-14",
  "rows": [
    {
      "row_id": "abaloparatide",
      "ingredient": "Abaloparatide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Tymlos",
      "reference_application": "NDA 208743",
      "reference_application_original_approval_date": "2017-04-28",
      "route": "Subcutaneous",
      "selected_labeled_use": "Osteoporosis in eligible patients at high risk of fracture.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208743",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743s017lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic PTH-related peptide analog",
      "check_date": "2026-10-14",
      "notes": "Current FDA application record verified; 2025 FDA label read."
    },
    {
      "row_id": "afamelanotide",
      "ingredient": "Afamelanotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Scenesse",
      "reference_application": "NDA 210797",
      "reference_application_original_approval_date": "2019-10-08",
      "route": "Subcutaneous implant",
      "selected_labeled_use": "Increased pain-free light exposure in adults with phototoxic reactions from erythropoietic protoporphyria.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210797",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210797s007lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic linear melanocortin analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "angiotensin-ii",
      "ingredient": "Angiotensin II",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Giapreza",
      "reference_application": "NDA 209360",
      "reference_application_original_approval_date": "2017-12-21",
      "route": "Intravenous infusion",
      "selected_labeled_use": "Increase in blood pressure in adults with septic or other distributive shock.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209360",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209360s000lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic human angiotensin II octapeptide",
      "check_date": "2026-10-14",
      "notes": "Latest label PDF publicly linked in this live Drugs@FDA application record is the original 2017 label. Current selected indication also matches FDA's updated labeling directory; do not describe this PDF as the latest current manufacturer prescribing information."
    },
    {
      "row_id": "bivalirudin",
      "ingredient": "Bivalirudin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Angiomax",
      "reference_application": "NDA 020873",
      "reference_application_original_approval_date": "2000-12-15",
      "route": "Intravenous",
      "selected_labeled_use": "Anticoagulation during percutaneous coronary intervention, including eligible patients with HIT/HITTS.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020873",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020873s039lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic linear direct-thrombin-inhibitor peptide",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "bremelanotide",
      "ingredient": "Bremelanotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Vyleesi",
      "reference_application": "NDA 210557",
      "reference_application_original_approval_date": "2019-06-21",
      "route": "Subcutaneous",
      "selected_labeled_use": "Acquired, generalized hypoactive sexual desire disorder in eligible premenopausal women.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic heptapeptide",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "cetrorelix",
      "ingredient": "Cetrorelix",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Cetrotide",
      "reference_application": "NDA 021197",
      "reference_application_original_approval_date": "2000-08-11",
      "route": "Subcutaneous",
      "selected_labeled_use": "Inhibition of premature LH surges during controlled ovarian stimulation.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021197",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021197s030lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH decapeptide antagonist",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "cosyntropin",
      "ingredient": "Cosyntropin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Cortrosyn",
      "reference_application": "NDA 016750",
      "reference_application_original_approval_date": "1970-04-22",
      "route": "Intravenous or intramuscular",
      "selected_labeled_use": "With other diagnostic tests, screening for adrenocortical insufficiency in adults and children.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=016750",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016750s033lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic ACTH(1-24) polypeptide",
      "check_date": "2026-10-14",
      "notes": "This application's original approval date in live Drugs@FDA is 1970-04-22. Do not substitute the current label's Initial U.S. Approval field or an unsupported molecule-wide historical year."
    },
    {
      "row_id": "cyclosporine",
      "ingredient": "Cyclosporine",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Neoral; Restasis (examples)",
      "reference_application": "NDA 050715",
      "reference_application_original_approval_date": "1995-07-14",
      "route": "Oral (Neoral); ophthalmic (Restasis)",
      "selected_labeled_use": "Neoral: organ-rejection prevention after kidney/liver/heart transplants; specified severe active rheumatoid arthritis and severe recalcitrant plaque psoriasis. Restasis: increased tear production when suppressed by ocular inflammation associated with keratoconjunctivitis sicca.",
      "database_marketing_status": "Neoral 25-mg/100-mg capsules Prescription, 50-mg discontinued; Restasis and Restasis MultiDose Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050715",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050715s041,050716s041,050735s003,050736s001,050737s003,050738s001lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050790",
      "additional_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050790s031lbl.pdf",
      "classification_basis": "FDA Neoral label explicitly describes cyclosporine as a cyclic polypeptide consisting of 11 amino acids.",
      "check_date": "2026-10-14",
      "notes": "First ingredient U.S. approval is 1983 (Sandimmune), not Neoral's 1995 or Restasis's 2002 application approvals. Do not imply all formulations share indications or are interchangeable. Reference date is Neoral capsules (1995-07-14); Restasis approval 2002-12-23; original Sandimmune ingredient approval 1983-11-14."
    },
    {
      "row_id": "dalbavancin",
      "ingredient": "Dalbavancin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Dalvance",
      "reference_application": "NDA 021883",
      "reference_application_original_approval_date": "2014-05-23",
      "route": "Intravenous",
      "selected_labeled_use": "Acute bacterial skin and skin structure infections in adults and pediatric patients caused by specified susceptible bacteria.",
      "database_marketing_status": "Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021883",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021883Orig1s012lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "FDA label \u00a711/\u00a712.4 explicitly describes a lipoglycopeptide/semisynthetic lipoglycopeptide. A mixture of five closely related active homologs.",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "daptomycin",
      "ingredient": "Daptomycin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Generic daptomycin (current); Cubicin (discontinued reference brand)",
      "reference_application": "NDA 021572",
      "reference_application_original_approval_date": "2003-09-12",
      "route": "Intravenous",
      "selected_labeled_use": "Specified complicated skin infections and Staphylococcus aureus bloodstream infections; includes right-sided infective endocarditis in adults. Not indicated for pneumonia.",
      "database_marketing_status": "Original Cubicin/Cubicin RF examples discontinued; generic ANDA 205037 listed Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021572",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021572s070lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205037",
      "additional_label_url": "",
      "classification_basis": "FDA label \u00a711 explicitly describes daptomycin as a cyclic lipopeptide antibacterial.",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "desmopressin",
      "ingredient": "Desmopressin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "DDAVP Injection",
      "reference_application": "NDA 018938",
      "reference_application_original_approval_date": "1984-03-30",
      "route": "Intravenous or subcutaneous",
      "selected_labeled_use": "Central diabetes insipidus and specified bleeding disorders, including eligible hemophilia A/von Willebrand disease cases.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018938",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018938Orig1s039lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Modified vasopressin analog",
      "check_date": "2026-10-14",
      "notes": "Current FDA application page verified by parent via Firecrawl; captured local evidence research/fda-record-018938.md"
    },
    {
      "row_id": "difelikefalin",
      "ingredient": "Difelikefalin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Korsuva",
      "reference_application": "NDA 214916",
      "reference_application_original_approval_date": "2021-08-23",
      "route": "Intravenous",
      "selected_labeled_use": "Moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214916",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214916s002lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Four-amino-acid core with terminal piperidine-carboxylic-acid group",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "elamipretide",
      "ingredient": "Elamipretide",
      "aliases": "SS-31; elamipretide hydrochloride",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Forzinity",
      "reference_application": "NDA 215244",
      "reference_application_original_approval_date": "2025-09-19",
      "route": "Subcutaneous injection",
      "selected_labeled_use": "Improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg; accelerated approval.",
      "database_marketing_status": "At least one example-product presentation is listed Prescription or Rx",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000IntegratedR.pdf",
      "additional_label_url": "",
      "classification_basis": "Approval applies to Forzinity; it does not approve products sold as research SS-31. FDA chemistry review describes a tetrapeptide.",
      "check_date": "2026-10-14",
      "notes": "Approval applies to Forzinity; it does not approve products sold as research SS-31. FDA chemistry review describes a tetrapeptide."
    },
    {
      "row_id": "enlicitide",
      "ingredient": "Enlicitide",
      "aliases": "enlicitide decanoate",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Lipfendra",
      "reference_application": "NDA 220848",
      "reference_application_original_approval_date": "2026-07-15",
      "route": "Oral tablet",
      "selected_labeled_use": "Reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, with diet and exercise.",
      "database_marketing_status": "At least one example-product presentation is listed Prescription or Rx",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220848",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220848Orig1s000lbl.pdf",
      "additional_record_url": "https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026",
      "additional_label_url": "",
      "classification_basis": "FDA label calls enlicitide a macrocyclic peptide. Active ingredient recorded as enlicitide decanoate.",
      "check_date": "2026-10-14",
      "notes": "FDA label calls enlicitide a macrocyclic peptide. Active ingredient recorded as enlicitide decanoate."
    },
    {
      "row_id": "eptifibatide",
      "ingredient": "Eptifibatide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Generic eptifibatide (current); Integrilin (discontinued reference brand)",
      "reference_application": "NDA 020718",
      "reference_application_original_approval_date": "1998-05-18",
      "route": "Intravenous",
      "selected_labeled_use": "Reduces death or new myocardial infarction in specified acute coronary syndrome patients; also indicated during percutaneous coronary intervention.",
      "database_marketing_status": "Original Integrilin brand discontinued; generic ANDA 213081 listed Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020718",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020718s039lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213081",
      "additional_label_url": "",
      "classification_basis": "FDA label \u00a711: cyclic heptapeptide containing six amino acids and one mercaptopropionyl (des-amino cysteinyl) residue.",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "etelcalcetide",
      "ingredient": "Etelcalcetide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Parsabiv",
      "reference_application": "NDA 208325",
      "reference_application_original_approval_date": "2017-02-07",
      "route": "Intravenous",
      "selected_labeled_use": "Secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208325",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208325s002lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Seven-residue D-amino-acid chain disulfide-linked to L-cysteine",
      "check_date": "2026-10-14",
      "notes": "Drugs@FDA lists a 2021 labeling supplement without an available label PDF. The linked 2019 label supports the selected indication and peptide description; use the application record for status."
    },
    {
      "row_id": "ganirelix",
      "ingredient": "Ganirelix",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Ganirelix Acetate Injection",
      "reference_application": "NDA 021057",
      "reference_application_original_approval_date": "1999-07-29",
      "route": "Subcutaneous",
      "selected_labeled_use": "Inhibition of premature LH surges during controlled ovarian hyperstimulation.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021057",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021057s024lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH decapeptide antagonist",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "glucagon",
      "ingredient": "Glucagon",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Baqsimi",
      "reference_application": "NDA 210134",
      "reference_application_original_approval_date": "2019-07-24",
      "route": "Intranasal",
      "selected_labeled_use": "Severe hypoglycemia in eligible patients with diabetes.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210134",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210134s004lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Single-chain glucagon polypeptide",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "goserelin",
      "ingredient": "Goserelin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Zoladex 3.6 mg",
      "reference_application": "NDA 019726",
      "reference_application_original_approval_date": "1989-12-29",
      "route": "Subcutaneous implant",
      "selected_labeled_use": "Selected prostate/breast cancer indications, endometriosis, and endometrial thinning.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019726",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019726s074,020515s011lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH decapeptide analog",
      "check_date": "2026-10-14",
      "notes": "Current FDA application record and 2025 FDA label verified."
    },
    {
      "row_id": "histrelin",
      "ingredient": "Histrelin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Supprelin LA",
      "reference_application": "NDA 022058",
      "reference_application_original_approval_date": "2007-05-03",
      "route": "Subcutaneous implant",
      "selected_labeled_use": "Central precocious puberty in children.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022058",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022058s020lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH nonapeptide analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "human-secretin",
      "ingredient": "Human secretin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "ChiRhoStim",
      "reference_application": "NDA 021256",
      "reference_application_original_approval_date": "2004-04-09",
      "route": "Intravenous",
      "selected_labeled_use": "Stimulation tests aiding diagnosis of pancreatic exocrine dysfunction or gastrinoma; pancreatic secretion stimulation during ERCP.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021256",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic human secretin peptide",
      "check_date": "2026-10-14",
      "notes": "Current application original approval is April9 2004; do not use marketing-start dates from structured drug listings."
    },
    {
      "row_id": "icatibant",
      "ingredient": "Icatibant",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Firazyr",
      "reference_application": "NDA 022150",
      "reference_application_original_approval_date": "2011-08-25",
      "route": "Subcutaneous",
      "selected_labeled_use": "Acute hereditary angioedema attacks in adults.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022150",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022150s016lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic decapeptide bradykinin B2 antagonist",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "lanreotide",
      "ingredient": "Lanreotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Somatuline Depot",
      "reference_application": "NDA 022074",
      "reference_application_original_approval_date": "2007-08-30",
      "route": "Subcutaneous",
      "selected_labeled_use": "Acromegaly, selected gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022074",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022074s032lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic octapeptide",
      "check_date": "2026-10-14",
      "notes": "Current FDA application page verified by parent via Firecrawl; captured local evidence research/fda-record-022074.md"
    },
    {
      "row_id": "leuprolide",
      "ingredient": "Leuprolide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Lupron Depot 7.5 mg",
      "reference_application": "NDA 019732",
      "reference_application_original_approval_date": "1989-01-26",
      "route": "Intramuscular",
      "selected_labeled_use": "Palliative treatment of advanced prostate cancer.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019732",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019732s050,020517s047lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH nonapeptide analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "linaclotide",
      "ingredient": "Linaclotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Linzess",
      "reference_application": "NDA 202811",
      "reference_application_original_approval_date": "2012-08-30",
      "route": "Oral",
      "selected_labeled_use": "Irritable bowel syndrome with constipation, chronic idiopathic constipation, and functional constipation in the age groups named in the label.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202811s023lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Peptide with three disulfide bonds",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "liraglutide",
      "ingredient": "Liraglutide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Victoza",
      "reference_application": "NDA 022341",
      "reference_application_original_approval_date": "2010-01-25",
      "route": "Subcutaneous",
      "selected_labeled_use": "Type 2 diabetes and specified cardiovascular risk reduction in eligible adults.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022341",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Peptide acylated GLP-1 analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "motixafortide",
      "ingredient": "Motixafortide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Aphexda",
      "reference_application": "NDA 217159",
      "reference_application_original_approval_date": "2023-09-08",
      "route": "Subcutaneous",
      "selected_labeled_use": "With filgrastim, mobilization of hematopoietic stem cells for collection and autologous transplant in multiple myeloma.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217159",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217159s009lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic CXCR4 antagonist peptide",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "octreotide",
      "ingredient": "Octreotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Sandostatin Injection",
      "reference_application": "NDA 019667",
      "reference_application_original_approval_date": "1988-10-21",
      "route": "Subcutaneous or intravenous",
      "selected_labeled_use": "Acromegaly and control of specified carcinoid/VIPoma-associated symptoms.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019667",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019667s078lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic octapeptide",
      "check_date": "2026-10-14",
      "notes": "Current FDA application page verified by parent via Firecrawl; captured local evidence research/fda-record-019667.md"
    },
    {
      "row_id": "oritavancin",
      "ingredient": "Oritavancin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Orbactiv (verified example)",
      "reference_application": "NDA 206334",
      "reference_application_original_approval_date": "2014-08-06",
      "route": "Intravenous",
      "selected_labeled_use": "Acute bacterial skin and skin structure infections in adults caused by specified susceptible Gram-positive bacteria.",
      "database_marketing_status": "Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206334",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206334s007lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "FDA label \u00a711 explicitly describes a semisynthetic lipoglycopeptide antibacterial.",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "oxytocin",
      "ingredient": "Oxytocin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Pitocin",
      "reference_application": "NDA 018261",
      "reference_application_original_approval_date": "1980-11-19",
      "route": "Intravenous infusion or intramuscular injection",
      "selected_labeled_use": "Medically indicated initiation or reinforcement of labor and control of postpartum bleeding or hemorrhage.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018261",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018261Orig1s041lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic nonapeptide",
      "check_date": "2026-10-14",
      "notes": "This application's original approval date is 1980-11-19; do not present it as first-ever oxytocin approval. Pitocin NDA is 018261, not oxytocin NDA018248."
    },
    {
      "row_id": "pasireotide",
      "ingredient": "Pasireotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Signifor",
      "reference_application": "NDA 200677",
      "reference_application_original_approval_date": "2012-12-14",
      "route": "Subcutaneous",
      "selected_labeled_use": "Cushing's disease when pituitary surgery is not an option or has not been curative.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200677",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200677s012lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic hexapeptide",
      "check_date": "2026-10-14",
      "notes": "Current FDA application page verified by parent via Firecrawl; captured local evidence research/fda-record-200677.md"
    },
    {
      "row_id": "pegcetacoplan",
      "ingredient": "Pegcetacoplan",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Empaveli; Syfovre",
      "reference_application": "NDA 215014",
      "reference_application_original_approval_date": "2021-05-14",
      "route": "Subcutaneous (Empaveli); intravitreal (Syfovre)",
      "selected_labeled_use": "Empaveli: adults with paroxysmal nocturnal hemoglobinuria; patients aged 12+ with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis, to reduce proteinuria and loss of kidney function. Syfovre: geographic atrophy secondary to age-related macular degeneration.",
      "database_marketing_status": "Prescription for both applications",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215014",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215014s012lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217171",
      "additional_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217171Orig1s003lbl.pdf",
      "classification_basis": "FDA Empaveli label \u00a711: two identical pentadecapeptides covalently attached to a linear 40-kDa PEG molecule. Include as a PEG-conjugated peptide; molecule mass does not equal amino-acid chain length.",
      "check_date": "2026-10-14",
      "notes": " Syfovre original application approval: 2023-02-17; reference date is Empaveli only."
    },
    {
      "row_id": "plecanatide",
      "ingredient": "Plecanatide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Trulance",
      "reference_application": "NDA 208745",
      "reference_application_original_approval_date": "2017-01-19",
      "route": "Oral",
      "selected_labeled_use": "Chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208745",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Peptide with two disulfide bonds",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "rusfertide",
      "ingredient": "Rusfertide",
      "aliases": "rusfertide acetate",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Mimrylo",
      "reference_application": "NDA 220605",
      "reference_application_original_approval_date": "2026-08-28",
      "route": "Subcutaneous injection",
      "selected_labeled_use": "Treat erythrocytosis (excess red blood cells) in adults with polycythemia vera.",
      "database_marketing_status": "At least one example-product presentation is listed Prescription or Rx",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220605",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220605Orig1s000lbl.pdf",
      "additional_record_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder",
      "additional_label_url": "",
      "classification_basis": "FDA label calls rusfertide a synthetic cyclic peptide. Sequence in label contains 17 backbone residues plus modification; count not used in headline.",
      "check_date": "2026-10-14",
      "notes": "FDA label calls rusfertide a synthetic cyclic peptide. Sequence in label contains 17 backbone residues plus modification; count not used in headline."
    },
    {
      "row_id": "semaglutide",
      "ingredient": "Semaglutide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Ozempic",
      "reference_application": "NDA 209637",
      "reference_application_original_approval_date": "2017-12-05",
      "route": "Subcutaneous",
      "selected_labeled_use": "Type 2 diabetes and specified cardiovascular/kidney risk reduction in eligible adults.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Peptide modified GLP-1 analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "setmelanotide",
      "ingredient": "Setmelanotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Imcivree",
      "reference_application": "NDA 213793",
      "reference_application_original_approval_date": "2020-11-25",
      "route": "Subcutaneous",
      "selected_labeled_use": "Specified rare genetic/syndromic obesity and acquired hypothalamic obesity.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213793",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213793s009lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic cyclic melanocortin analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "teduglutide",
      "ingredient": "Teduglutide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Gattex",
      "reference_application": "NDA 203441",
      "reference_application_original_approval_date": "2012-12-21",
      "route": "Subcutaneous",
      "selected_labeled_use": "Short bowel syndrome in eligible patients dependent on parenteral support.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203441",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203441s022lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Recombinant GLP-2 analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "telavancin",
      "ingredient": "Telavancin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Vibativ",
      "reference_application": "NDA 022110",
      "reference_application_original_approval_date": "2009-09-11",
      "route": "Intravenous",
      "selected_labeled_use": "Specified complicated skin infections in adults; hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Staphylococcus aureus when alternative treatments are unsuitable.",
      "database_marketing_status": "750-mg vial Prescription; 250-mg vial Discontinued",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022110",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022110s016lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "FDA label \u00a711 describes a lipoglycopeptide synthetic derivative of vancomycin.",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "teriparatide",
      "ingredient": "Teriparatide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Forteo",
      "reference_application": "NDA 021318",
      "reference_application_original_approval_date": "2002-11-26",
      "route": "Subcutaneous",
      "selected_labeled_use": "Osteoporosis in eligible patients at high risk of fracture, including certain glucocorticoid-associated cases.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021318",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021318Orig1s059lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Recombinant PTH(1-34) analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "tirzepatide",
      "ingredient": "Tirzepatide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Mounjaro",
      "reference_application": "NDA 215866",
      "reference_application_original_approval_date": "2022-05-13",
      "route": "Subcutaneous",
      "selected_labeled_use": "Type 2 diabetes with diet and exercise; cardiovascular-event risk reduction in adults with type 2 diabetes at high risk (Mounjaro).",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215866",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s044s045lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Peptide modified GIP/GLP-1 analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "triptorelin",
      "ingredient": "Triptorelin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Trelstar 3.75 mg",
      "reference_application": "NDA 020715",
      "reference_application_original_approval_date": "2000-06-15",
      "route": "Intramuscular",
      "selected_labeled_use": "Advanced prostate cancer.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020715",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020715s052lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic GnRH decapeptide analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "vasopressin",
      "ingredient": "Vasopressin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Vasostrict",
      "reference_application": "NDA 204485",
      "reference_application_original_approval_date": "2014-04-17",
      "route": "Intravenous",
      "selected_labeled_use": "Adult vasodilatory shock with hypotension despite fluids and catecholamines.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204485",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204485Orig1s030lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic arginine vasopressin",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "voclosporin",
      "ingredient": "Voclosporin",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Lupkynis",
      "reference_application": "NDA 213716",
      "reference_application_original_approval_date": "2021-01-22",
      "route": "Oral",
      "selected_labeled_use": "Active lupus nephritis in adults, in combination with a background immunosuppressive regimen.",
      "database_marketing_status": "Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213716",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213716s008lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "FDA draft Clinical Pharmacology Considerations for Peptide Drug Products specifically gives voclosporin as a cyclic peptide example. Label \u00a711 chemical name/structure confirms cyclic peptide structure.",
      "check_date": "2026-10-14",
      "notes": "FDA peptide guidance remains draft/nonbinding. It supports classification, not the approval status; status is supported by Drugs@FDA."
    },
    {
      "row_id": "vosoritide",
      "ingredient": "Vosoritide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Voxzogo",
      "reference_application": "NDA 214938",
      "reference_application_original_approval_date": "2021-11-19",
      "route": "Subcutaneous",
      "selected_labeled_use": "Increased linear growth in pediatric achondroplasia with open epiphyses.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214938",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214938s004lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Recombinant C-type natriuretic peptide analog",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "ziconotide",
      "ingredient": "Ziconotide",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Prialt",
      "reference_application": "NDA 021060",
      "reference_application_original_approval_date": "2004-12-28",
      "route": "Intrathecal",
      "selected_labeled_use": "Severe chronic pain in adults for whom intrathecal therapy is warranted.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021060",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021060s012lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic conopeptide with three disulfide bridges",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "zilucoplan",
      "ingredient": "Zilucoplan",
      "aliases": "",
      "inclusion_group": "peptide_or_modified_peptide",
      "example_product": "Zilbrysq",
      "reference_application": "NDA 216834",
      "reference_application_original_approval_date": "2023-10-17",
      "route": "Subcutaneous",
      "selected_labeled_use": "Generalized myasthenia gravis in anti-AChR-antibody-positive adults.",
      "database_marketing_status": "At least one example-product strength is listed as Prescription",
      "record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216834",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216834s013lbl.pdf",
      "additional_record_url": "",
      "additional_label_url": "",
      "classification_basis": "Synthetic macrocyclic peptide complement inhibitor",
      "check_date": "2026-10-14",
      "notes": ""
    },
    {
      "row_id": "bulevirtide-gmod",
      "ingredient": "Bulevirtide-gmod",
      "aliases": "bulevirtide",
      "inclusion_group": "larger_protein_or_fusion",
      "example_product": "Hepcludex",
      "reference_application": "BLA 761468",
      "reference_application_original_approval_date": "2026-05-22",
      "route": "Subcutaneous injection",
      "selected_labeled_use": "Treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis; accelerated approval.",
      "database_marketing_status": "At least one example-product presentation is listed Prescription or Rx",
      "record_url": "https://purplebooksearch.fda.gov/index.cfm?event=productdetails&blaNo=761468",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761468Orig1s000lbl.pdf",
      "additional_record_url": "https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection",
      "additional_label_url": "",
      "classification_basis": "FDA label describes a 47-amino-acid protein/lipopeptide. Kept separate from short-peptide table.",
      "check_date": "2026-10-14",
      "notes": "FDA label describes a 47-amino-acid protein/lipopeptide. Kept separate from short-peptide table."
    },
    {
      "row_id": "dulaglutide",
      "ingredient": "Dulaglutide",
      "aliases": "",
      "inclusion_group": "larger_protein_or_fusion",
      "example_product": "Trulicity",
      "reference_application": "BLA 125469",
      "reference_application_original_approval_date": "2014-09-18",
      "route": "Subcutaneous",
      "selected_labeled_use": "Type 2 diabetes in adults and children aged 10 years or older, with diet and exercise; reduce major cardiovascular events in eligible adults with type 2 diabetes.",
      "database_marketing_status": "Current autoinjector presentations listed Rx in Purple Book and Prescription in Drugs@FDA.",
      "record_url": "https://purplebooksearch.fda.gov/index.cfm?blaNo=125469&event=productdetails",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125469s065lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=125469&event=overview.process",
      "additional_label_url": "",
      "classification_basis": "GLP-1 analog\u2013IgG4 Fc fusion protein",
      "check_date": "2026-10-14",
      "notes": "Latest linked FDA labeling supplement March 12, 2026; original application approval September 18, 2014."
    },
    {
      "row_id": "human-insulin",
      "ingredient": "Human insulin",
      "aliases": "",
      "inclusion_group": "larger_protein_or_fusion",
      "example_product": "Humulin R U-500 (selected prescription example)",
      "reference_application": "BLA 018780",
      "reference_application_original_approval_date": "1982-10-28",
      "route": "Subcutaneous",
      "selected_labeled_use": "Diabetes in adults and children with high insulin requirements; concentrated human insulin formulation (selected U-500 example).",
      "database_marketing_status": "Humulin R U-500 vial and KwikPen listed Rx; U-100 vials listed OTC in Purple Book.",
      "record_url": "https://purplebooksearch.fda.gov/index.cfm?blaNo=018780&event=productdetails",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=018780&event=overview.process",
      "additional_label_url": "",
      "classification_basis": "51-amino-acid, two-chain human insulin protein",
      "check_date": "2026-10-14",
      "notes": "The original Humulin R application approval date is October 28, 1982. The selected U-500 formulation's label lists initial U.S. approval 1994. The latest application label PDF from June 27, 2022 contains both U-100 and U-500 labeling despite the database note mentioning only U-100; U-500 starts on PDF page 18. U-500 route is subcutaneous only."
    },
    {
      "row_id": "tesamorelin",
      "ingredient": "Tesamorelin",
      "aliases": "",
      "inclusion_group": "larger_protein_or_fusion",
      "example_product": "Egrifta SV; Egrifta WR",
      "reference_application": "BLA 022505",
      "reference_application_original_approval_date": "2010-11-10",
      "route": "Subcutaneous",
      "selected_labeled_use": "Reduce excess abdominal fat in HIV-infected adults with lipodystrophy; not indicated for weight-loss management.",
      "database_marketing_status": "Egrifta SV 2 mg and Egrifta WR 11.6 mg listed Rx; original Egrifta 1 mg listed discontinued in Purple Book.",
      "record_url": "https://purplebooksearch.fda.gov/index.cfm?blaNo=022505&event=productdetails",
      "label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf",
      "additional_record_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=022505&event=overview.process",
      "additional_label_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf",
      "classification_basis": "44-amino-acid GRF analog with N-terminal hexenoyl modification",
      "check_date": "2026-10-14",
      "notes": "WR supplement approved March 25, 2025; original application approval date remains November 10, 2010. SV and WR formulations are not substitutable. WR is injected daily; one mixed vial supplies seven daily doses."
    }
  ]
}