{"schemaVersion":"peptidescanner-evidence-object/v1","objectId":"story:fda-drugs-anda213829:v1","objectPathId":"fda-drugs-anda213829-v1","kind":"story-version","urls":{"story":"https://peptidescanner.com/stories/fda-drugs-anda213829/","json":"https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda213829-v1.json","markdown":"https://peptidescanner.com/evidence/v1/objects/fda-drugs-anda213829-v1.md"},"story":{"slug":"fda-drugs-anda213829","version":1,"domain":"Regulatory","dateInSource":"2021-08-13","sourceCheckedAt":"2026-08-14","publishedAt":"2026-08-14","peptideSlugs":["leuprolide"],"peptides":[{"slug":"leuprolide","url":"https://peptidescanner.com/peptides/leuprolide/"}]},"claims":[{"id":"headline","text":"Drugs@FDA application ANDA213829","sourceIds":["fda-drugs-anda213829-2021-08-13-de3816b22ef8"]},{"id":"summary","text":"The official Drugs@FDA dataset lists original submission 1 for ANDA 213829 with status AP dated 2021-08-13, and names leuprolide acetate among the application record's active ingredients.","sourceIds":["fda-drugs-anda213829-2021-08-13-de3816b22ef8"]},{"id":"paragraph-1","text":"The official Drugs@FDA dataset lists original submission 1 for ANDA 213829 with status AP dated 2021-08-13, and names leuprolide acetate among the application record's active ingredients.","sourceIds":["fda-drugs-anda213829-2021-08-13-de3816b22ef8"]},{"id":"paragraph-2","text":"This page reports bounded application metadata attributed to Drugs@FDA. It does not reproduce labeling, describe an indication, compare products, or provide medical guidance.","sourceIds":["fda-drugs-anda213829-2021-08-13-de3816b22ef8"]}],"sources":[{"id":"fda-drugs-anda213829-2021-08-13-de3816b22ef8","name":"Drugs@FDA via openFDA","sourceClass":"A","title":"Drugs@FDA application ANDA213829 · original submission status AP · 2021-08-13 · dataset 2026-08-13","url":"https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22ANDA213829%22&limit=1"}],"correction":{"state":"none"},"boundaries":{"scope":"selected-public-evidence-only","reporting":"PeptideScanner reports the cited regulator or label record. It does not extend that record into broader safety, effectiveness, or approval claims.","unknowns":["Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.","This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.","This object does not determine safety, efficacy, causality, or suitability for any person."],"methodologyUrl":"https://peptidescanner.com/methodology/","medicalDisclaimerUrl":"https://peptidescanner.com/medical-disclaimer/"},"commitments":{"publicationLedgerSha256":"f34d280c21693907020647ec8086071d17a01dd78ecd226da5aab8f8381a0396","tierARecordSha256":"de3816b22ef8fcefad8e82ff227cc3676320fb91955fa273ee48cd2ec06fa57f"},"integrity":{"algorithm":"sha256","contentSha256":"33097e3dc4b6ce70ef0ad265e778c74d9f65a18ff1d7b70406b1941b87122482"}}