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FDA NDA · NDA022252

NATAZIA

estradiol valerate and estradiol valerate/dienogest

Sponsor: BAYER HLTHCARE

APPLICATION
NDA022252
TYPE
NDA
ORIGINAL APPROVAL
2010-05-06
LATEST ACTION
2024-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NATAZIA · ReferencePrescription
DIENOGEST N/A,2MG,3MG,N/A,N/A, ESTRADIOL VALERATE 3MG,2MG,2MG,1MG,N/A · TABLET · ORAL

Approval history

2024-06-26Labeling · Supplement 9 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 7 · standard — Label ↗AP
2015-08-21Labeling · Supplement 4 · standard — Label ↗AP
2013-08-22Labeling · Supplement 3 · standard — Label ↗AP
2012-03-14Efficacy · Original · standard — Label ↗AP
2012-02-13Efficacy · Supplement 1 · standard — Label ↗AP
2010-05-06Type 1 - New Molecular Entity and Type 4 - New Combination · 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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