← FDA DRUG APPROVALS

FDA NDA · NDA010402

PREMARIN

conjugated estrogens

Sponsor: WYETH PHARMS

APPLICATION
NDA010402
TYPE
NDA
ORIGINAL APPROVAL
1956-12-18
LATEST ACTION
2024-02-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 25MG/VIAL · INJECTABLE · INJECTION

Approval history

2024-02-15Labeling · Supplement 73 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 68 · standard — Label ↗AP
2012-04-11Labeling · Supplement 63 · unknown — Label ↗AP
2008-03-03Labeling · Supplement 55 · standard — Letter ↗AP
2006-07-26Labeling · Supplement 50 · standard — Letter ↗AP
2006-06-01Manufacturing (CMC) · Supplement 51 · standard — Letter ↗AP
2005-08-30Labeling · Supplement 48 · standard — Letter ↗AP
2005-01-14Labeling · Supplement 47 · standard — Letter ↗AP
2004-04-20Labeling · Supplement 46 · standard — Label ↗AP
2002-10-17Manufacturing (CMC) · Supplement 42 · standardAP
2002-10-09Manufacturing (CMC) · Supplement 43 · standardAP
1998-05-29Labeling · Supplement 35 · standardAP
1995-12-14Manufacturing (CMC) · Supplement 34 · standardAP
1995-02-06Manufacturing (CMC) · Supplement 33 · standardAP
1993-07-12Manufacturing (CMC) · Supplement 31 · standardAP
1993-02-24Labeling · Supplement 32 · standardAP
1989-11-27Manufacturing (CMC) · Supplement 30 · standardAP
1989-09-26Manufacturing (CMC) · Supplement 29 · standardAP
1989-09-11Labeling · Supplement 24AP
1989-03-02Manufacturing (CMC) · Supplement 27 · standardAP
1988-01-28Manufacturing (CMC) · Supplement 26 · standardAP
1986-01-07Manufacturing (CMC) · Supplement 25 · standardAP
1985-04-29Labeling · Supplement 23AP
1956-12-18Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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