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FDA NDA · NDA022014

EVAMIST

estradiol

Sponsor: PADAGIS US

APPLICATION
NDA022014
TYPE
NDA
ORIGINAL APPROVAL
2007-07-27
LATEST ACTION
2024-02-15
ROUTE
TRANSDERMAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

EVAMIST · ReferencePrescription
ESTRADIOL 1.53MG/SPRAY · SPRAY · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 15 · standard — Letter ↗AP
2023-08-03Labeling · Supplement 14 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 13 · standard — Label ↗AP
2014-03-11Labeling · Supplement 6 · standard — Label ↗AP
2013-01-15Manufacturing (CMC) · Supplement 12 · standardAP
2011-10-26Labeling · Supplement 9 · unknown — Label ↗AP
2008-10-30Labeling · Supplement 5 · standard — Letter ↗AP
2008-04-11Labeling · Supplement 1 · standard — Label ↗AP
2007-07-27Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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