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FDA NDA · NDA008975

PURIFIED CORTROPHIN GEL

repository corticotropin

Sponsor: ANI PHARMS

APPLICATION
NDA008975
TYPE
NDA
ORIGINAL APPROVAL
1954-06-16
LATEST ACTION
2025-02-28
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

PURIFIED CORTROPHIN GELDiscontinued
CORTICOTROPIN 40 UNITS/ML · INJECTABLE · INJECTION
PURIFIED CORTROPHIN GEL · ReferencePrescription
CORTICOTROPIN 80 UNITS/ML · INJECTABLE · INJECTION

Approval history

2025-02-28Manufacturing (CMC) · Supplement 16 — Label ↗AP
2024-12-13Labeling · Supplement 15 · standard — Label ↗AP
2023-10-26Labeling · Supplement 12 · standard — Letter ↗AP
2021-10-29Manufacturing (CMC) · Supplement 8 — Review ↗AP
1977-12-08Labeling · Supplement 6AP
1977-05-25Labeling · Supplement 5AP
1954-06-16Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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