← FDA DRUG APPROVALS

FDA NDA · NDA004782

CONJUGATED ESTROGENS

estrogens, conjugated

Sponsor: WYETH PHARMS

APPLICATION
NDA004782
TYPE
NDA
ORIGINAL APPROVAL
1942-05-08
LATEST ACTION
2025-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

PREMARINDiscontinued
ESTROGENS, CONJUGATED 2.5MG · TABLET · ORAL
PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 0.9MG · TABLET · ORAL
PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 0.3MG · TABLET · ORAL
PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 1.25MG · TABLET · ORAL
PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 0.45MG · TABLET · ORAL
PREMARIN · ReferencePrescription
ESTROGENS, CONJUGATED 0.625MG · TABLET · ORAL

Approval history

2025-04-22Labeling · Supplement 179 · standard — Label ↗AP
2024-02-15Labeling · Supplement 181 · standard — Letter ↗AP
2017-11-07Labeling · Supplement 176 · standard — Letter ↗AP
2015-09-01Manufacturing (CMC) · Supplement 173 · standardAP
2015-06-09Manufacturing (CMC) · Supplement 172 · standardAP
2014-12-03Labeling · Supplement 171 · standard — Letter ↗AP
2014-04-11Manufacturing (CMC) · Supplement 163 · standardAP
2011-10-28Labeling · Supplement 164 · unknown — Letter ↗AP
2011-10-28Labeling · Supplement 162 · unknown — Letter ↗AP
2011-10-28Labeling · Supplement 167 · unknown — Letter ↗AP
2008-03-03Labeling · Supplement 155 · standard — Letter ↗AP
2006-09-05Labeling · Supplement 147 · standard — Letter ↗AP
2006-04-24Labeling · Supplement 146 · standard — Letter ↗AP
2005-11-01Manufacturing (CMC) · Supplement 142 · standard — Letter ↗AP
2005-08-01Manufacturing (CMC) · Supplement 141 · standard — Letter ↗AP
2005-04-07Labeling · Supplement 138 · standard — Letter ↗AP
2005-04-07Labeling · Supplement 139 · standard — Letter ↗AP
2004-08-26Manufacturing (CMC) · Supplement 137 · standard — Letter ↗AP
2004-04-20Labeling · Supplement 133 · standard — Letter ↗AP
2004-04-20Labeling · Supplement 136 · standard — Letter ↗AP
2003-07-16Labeling · Supplement 125 · standard — Letter ↗AP
2003-04-24Efficacy · Supplement 115 · standard — Letter ↗AP
2003-04-24Labeling · Supplement 130 · standard — Letter ↗AP
2003-01-07Labeling · Supplement 129 · standard — Letter ↗AP
2002-12-20Manufacturing (CMC) · Supplement 126 · standardAP
2002-11-27Labeling · Supplement 128 · standard — Letter ↗AP
2002-08-21Manufacturing (CMC) · Supplement 124 · standardAP
2001-12-03Manufacturing (CMC) · Supplement 121 · standardAP
2001-08-06Manufacturing (CMC) · Supplement 120 · standardAP
2001-04-24Manufacturing (CMC) · Supplement 116 · standardAP
2000-07-05Manufacturing (CMC) · Supplement 113 · standardAP
1999-06-08Labeling · Supplement 109 · standardAP
1999-04-26Manufacturing (CMC) · Supplement 86 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 108 · standardAP
1998-09-08Efficacy · Supplement 93 · unknown — Letter ↗AP
1998-05-06Labeling · Supplement 104 · standardAP
1998-05-06Labeling · Supplement 96 · standardAP
1998-02-27Manufacturing (CMC) · Supplement 101 · standardAP
1996-06-28Manufacturing (CMC) · Supplement 103 · standardAP
1996-06-27Manufacturing (CMC) · Supplement 102 · standardAP
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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