← FDA DRUG APPROVALS

FDA NDA · NDA020216

PREMARIN VAGINAL

conjugated estrogens

Sponsor: WYETH PHARMS

APPLICATION
NDA020216
TYPE
NDA
ORIGINAL APPROVAL
1978-10-16
LATEST ACTION
2025-04-22
ROUTE
VAGINAL, TOPICAL, VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 0.625MG/GM · CREAM · TOPICAL, VAGINAL

Approval history

2025-04-22Labeling · Supplement 84 · standard — Label ↗AP
2024-02-15Labeling · Supplement 91 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 83 · standard — Label ↗AP
2015-12-28Labeling · Supplement 81 · standard — Letter ↗AP
2014-09-25Manufacturing (CMC) · Supplement 78AP
2012-02-14Labeling · Supplement 74 · unknown — Letter ↗AP
2012-02-14Labeling · Supplement 75 · unknown — Label ↗AP
2012-02-14Labeling · Supplement 73 · unknown — Label ↗AP
2011-04-22Labeling · Supplement 67 · standard — Letter ↗AP
2010-01-13Manufacturing (CMC) · Supplement 69AP
2008-11-07Efficacy · Supplement 60 · unknown — Review ↗AP
2008-03-03Labeling · Supplement 59 · standard — Letter ↗AP
2007-12-20Labeling · Supplement 56AP
2006-07-26Labeling · Supplement 55 · standard — Letter ↗AP
2005-08-30Labeling · Supplement 54 · standard — Label ↗AP
2005-01-14Labeling · Supplement 53 · standard — Letter ↗AP
2004-04-20Labeling · Supplement 52 · standard — Letter ↗AP
2002-05-08Manufacturing (CMC) · Supplement 50AP
1998-12-04Manufacturing (CMC) · Supplement 43 — Review ↗AP
1995-12-14Manufacturing (CMC) · Supplement 40AP
1995-08-30Manufacturing (CMC) · Supplement 38AP
1995-07-11Labeling · Supplement 39 · standardAP
1995-07-11Labeling · Supplement 37 · standardAP
1995-02-06Manufacturing (CMC) · Supplement 36AP
1994-10-14Manufacturing (CMC) · Supplement 34AP
1993-06-14Manufacturing (CMC) · Supplement 33 — Review ↗AP
1990-06-07Labeling · Supplement 31AP
1990-05-10Labeling · Supplement 30 — Review ↗AP
1988-02-12Manufacturing (CMC) · Supplement 25AP
1988-02-12Manufacturing (CMC) · Supplement 26AP
1985-12-17Manufacturing (CMC) · Supplement 19AP
1985-12-17Manufacturing (CMC) · Supplement 18 — Review ↗AP
1985-12-17Manufacturing (CMC) · Supplement 20AP
1985-11-07Manufacturing (CMC) · Supplement 17AP
1984-05-03Manufacturing (CMC) · Supplement 15AP
1982-10-05Manufacturing (CMC) · Supplement 6AP
1982-08-30Manufacturing (CMC) · Supplement 9AP
1982-08-30Manufacturing (CMC) · Supplement 7AP
1982-08-30Manufacturing (CMC) · Supplement 8AP
1978-10-16UNKNOWN · Original · unknown — Review ↗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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