FDA NDA · NDA009854
CORTROPHIN-ZINC
Sponsor: ANI PHARMS
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
NDA009854
TYPE
NDA
ORIGINAL APPROVAL
1955-07-29
LATEST ACTION
2026-10-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CORTROPHIN-ZINCDiscontinued
CORTICOTROPIN-ZINC HYDROXIDE 40 UNITS/ML · INJECTABLE · INJECTION
Approval history
1991-01-02Manufacturing (CMC) · Supplement 12 · priorityAP
1987-02-10Manufacturing (CMC) · Supplement 11 · priorityAP
1986-10-07Manufacturing (CMC) · Supplement 10 · priorityAP
1986-05-07Labeling · Supplement 8AP
1977-12-08Labeling · Supplement 7AP
1955-07-29Type 2 - New Active Ingredient · Original · priorityAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →