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FDA NDA · NDA022028

COSYNTROPIN

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APPLICATION
NDA022028
TYPE
NDA
ORIGINAL APPROVAL
2008-02-21
LATEST ACTION
2024-07-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

COSYNTROPINDiscontinued
COSYNTROPIN 0.25MG/ML (0.25MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-07-01Labeling · Supplement 7 · standard — Letter ↗AP
2021-07-16Labeling · Supplement 6 · standard — Letter ↗AP
2018-05-11Labeling · Supplement 5 · standard — Label ↗AP
2013-08-07Manufacturing (CMC) · Supplement 4 · standardAP
2008-02-21Type 5 - New Formulation or New Manufacturer · Original · standard — 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.

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