← FDA DRUG APPROVALS

FDA NDA · NDA203752

ESTRADIOL

Sponsor: NOVEN

APPLICATION
NDA203752
TYPE
NDA
ORIGINAL APPROVAL
2012-10-29
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MINIVELLE · ReferencePrescription
ESTRADIOL 0.1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
MINIVELLE · ReferencePrescription
ESTRADIOL 0.075MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
MINIVELLE · ReferencePrescription
ESTRADIOL 0.025MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
MINIVELLE · ReferencePrescription
ESTRADIOL 0.05MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
MINIVELLE · ReferencePrescription
ESTRADIOL 0.0375MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 22 · standard — Letter ↗AP
2021-10-19Labeling · Supplement 13 · standard — Label ↗AP
2021-10-19Labeling · Supplement 12 · standard — Label ↗AP
2021-10-12Labeling · Supplement 16 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 9 · standard — Label ↗AP
2014-11-10Manufacturing (CMC) · Supplement 6 · standardAP
2014-09-23Efficacy · Supplement 4 · standard — Label ↗AP
2014-05-21Manufacturing (CMC) · Supplement 2 · standardAP
2014-04-18Manufacturing (CMC) · Supplement 5 · standardAP
2012-10-29Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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