← FDA DRUG APPROVALS

FDA NDA · NDA020375

MENOSTAR

estradiol

Sponsor: BAYER HLTHCARE

APPLICATION
NDA020375
TYPE
NDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CLIMARA · ReferencePrescription
ESTRADIOL 0.06MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
CLIMARA · ReferencePrescription
ESTRADIOL 0.025MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
CLIMARA · ReferencePrescription
ESTRADIOL 0.1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
MENOSTARPrescription
ESTRADIOL 0.014MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
CLIMARA · ReferencePrescription
ESTRADIOL 0.0375MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
CLIMARA · ReferencePrescription
ESTRADIOL 0.075MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
CLIMARA · ReferencePrescription
ESTRADIOL 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 49 · standard — Letter ↗AP
2024-02-15Labeling · Supplement 50 · standard — Letter ↗AP
2021-09-30Labeling · Supplement 37 · standard — Label ↗AP
2021-09-30Labeling · Supplement 36 · standard — Label ↗AP
2021-09-16Labeling · Supplement 45 · standard — Letter ↗AP
2021-09-16Labeling · Supplement 46 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 35 · standard — Label ↗AP
2017-11-01Labeling · Supplement 34 · standard — Label ↗AP
2015-08-06Manufacturing (CMC) · Supplement 31 · standardAP
2013-10-10Labeling · Supplement 28 · standard — Letter ↗AP
2013-10-09Labeling · Supplement 27 · standard — Letter ↗AP
2013-05-14Manufacturing (CMC) · Supplement 30 · standardAP
2008-01-03Labeling · Supplement 26 · standard — Letter ↗AP
2007-03-28Manufacturing (CMC) · Supplement 24 · standardAP
2005-12-28Labeling · Supplement 23 · standard — Label ↗AP
2005-06-22Labeling · Supplement 22 · standard — Label ↗AP
2005-03-18Labeling · Supplement 21 · standard — Letter ↗AP
2004-01-22Labeling · Supplement 20 · standard — Label ↗AP
2002-12-19Manufacturing (CMC) · Supplement 18 · standardAP
2002-09-13Manufacturing (CMC) · Supplement 17 · standardAP
2001-04-05Efficacy · Supplement 16 · standard — Review ↗AP
2001-04-04Labeling · Supplement 14 · standard — Label ↗AP
1999-05-20Labeling · Supplement 13 · standard — Review ↗AP
1999-03-05Labeling · Supplement 11 · standard — Label ↗AP
1998-06-11Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1998-06-11Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
1998-03-23Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
1998-02-27Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1997-09-16Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1997-04-11Efficacy · Supplement 6 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1995-10-10Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1995-09-22Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1995-04-25Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1995-02-28Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1994-12-22Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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