← FDA DRUG APPROVALS

FDA NDA · NDA050682

COSMEGEN

Sponsor: RECORDATI RARE

APPLICATION
NDA050682
TYPE
NDA
ORIGINAL APPROVAL
1964-12-10
LATEST ACTION
2018-08-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

COSMEGEN · ReferenceDiscontinued
DACTINOMYCIN 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2018-08-15Efficacy · Supplement 34 · standard — Label ↗AP
2018-08-15Efficacy · Supplement 33 · standard — Label ↗AP
2015-04-07Manufacturing (CMC) · Supplement 31 · priorityAP
2012-02-03Labeling · Supplement 30 · unknown — Label ↗AP
2012-02-03Labeling · Supplement 29 · unknown — Label ↗AP
2009-03-13Labeling · Supplement 25 · standard — Letter ↗AP
2005-08-17Labeling · Supplement 22 · standard — Letter ↗AP
2004-11-30Labeling · Supplement 21 · standard — Letter ↗AP
2003-03-19Labeling · Supplement 20 · standard — Letter ↗AP
2002-10-28Labeling · Supplement 19 · standard — Letter ↗AP
2001-02-14Manufacturing (CMC) · Supplement 18 · priorityAP
2001-01-22Labeling · Supplement 17 · standardAP
2000-06-07Labeling · Supplement 13 · standardAP
1999-02-08Manufacturing (CMC) · Supplement 16 · priorityAP
1998-05-22Manufacturing (CMC) · Supplement 15 · priorityAP
1998-03-13Manufacturing (CMC) · Supplement 14 · priorityAP
1997-06-06Manufacturing (CMC) · Supplement 12 · priorityAP
1997-02-18Labeling · Supplement 10 · standardAP
1997-02-17Labeling · Supplement 9 · standardAP
1996-02-14Manufacturing (CMC) · Supplement 11 · priorityAP
1988-03-22Labeling · Supplement 7AP
1964-12-10Type 1 - New Molecular Entity · Original · priorityAP
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 →