← FDA DRUG APPROVALS

FDA ANDA · ANDA202147

COSYNTROPIN

Sponsor: SANDOZ

APPLICATION
ANDA202147
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
LATEST ACTION
2024-11-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

COSYNTROPINPrescription
COSYNTROPIN 0.25MG/VIAL · INJECTABLE · INJECTION

Approval history

2024-11-27Labeling · Supplement 17 · standardAP
2024-11-27Labeling · Supplement 18 · standardAP
2012-06-29Not Applicable · Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →