← FDA DRUG APPROVALS

FDA NDA · NDA009854

CORTROPHIN-ZINC

Sponsor: ANI PHARMS

APPLICATION
NDA009854
TYPE
NDA
ORIGINAL APPROVAL
1955-07-29
LATEST ACTION
1991-01-02
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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →