← FDA DRUG APPROVALS

FDA NDA · NDA020908

VAGIFEM

estradiol

Sponsor: NOVO NORDISK INC

APPLICATION
NDA020908
TYPE
NDA
ORIGINAL APPROVAL
1999-03-26
LATEST ACTION
2024-02-15
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

VAGIFEM · ReferenceDiscontinued
ESTRADIOL 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · VAGINAL
VAGIFEM · ReferencePrescription
ESTRADIOL 10MCG · TABLET · VAGINAL

Approval history

2024-02-15Labeling · Supplement 30 · standard — Letter ↗AP
2023-12-04Labeling · Supplement 29 · standard — Letter ↗AP
2022-09-29Labeling · Supplement 27 · standard — Letter ↗AP
2019-04-09Labeling · Supplement 26 · standard — Label ↗AP
2017-11-01Labeling · Supplement 25 · standard — Label ↗AP
2017-03-01Labeling · Supplement 24 · standard — Label ↗AP
2016-05-27Manufacturing (CMC) · Supplement 22 · standardAP
2016-04-04Manufacturing (CMC) · Supplement 23 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 21 · standardAP
2012-11-09Manufacturing (CMC) · Supplement 20 · standardAP
2012-04-11Labeling · Supplement 17 · unknown — Letter ↗AP
2011-05-17Labeling · Supplement 16 · standard — Letter ↗AP
2009-11-25Efficacy · Supplement 13 · unknown — Review ↗AP
2002-11-06Manufacturing (CMC) · Supplement 8 · standardAP
2002-09-05Manufacturing (CMC) · Supplement 7 · standardAP
2002-07-12Manufacturing (CMC) · Supplement 6 · standardAP
2001-09-06Manufacturing (CMC) · Supplement 5 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 4 · standardAP
2000-11-14Manufacturing (CMC) · Supplement 3 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 2 · standardAP
1999-11-03Manufacturing (CMC) · Supplement 1 · standardAP
1999-03-26Type 3 - New Dosage Form · Original · standard — Label ↗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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