← FDA DRUG APPROVALS

FDA NDA · NDA021676

YAZ

drospirenone and ethinyl estradiol

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021676
TYPE
NDA
ORIGINAL APPROVAL
2006-03-16
LATEST ACTION
2023-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

YAZ · ReferencePrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL

Approval history

2023-05-19Labeling · Supplement 20 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 21 · standard — Label ↗AP
2017-08-09Labeling · Supplement 19 · standard — Label ↗AP
2016-03-04Manufacturing (CMC) · Supplement 15 · standardAP
2015-07-31Manufacturing (CMC) · Supplement 17 · standardAP
2015-06-01Labeling · Supplement 14 · standard — Label ↗AP
2014-09-30Manufacturing (CMC) · Supplement 16 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 13 · standardAP
2012-04-10Labeling · Supplement 12 · standard — Label ↗AP
2011-03-11Efficacy · Supplement 8 · standard — Letter ↗AP
2010-04-07Labeling · Supplement 9 · unknown — Letter ↗AP
2007-01-26Labeling · Supplement 2 · standard — Letter ↗AP
2006-03-16Type 2 - New Active Ingredient · Original · standard — Review ↗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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