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FDA NDA · NDA021098

YASMIN

drospirenone and ethinyl estradiol

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021098
TYPE
NDA
ORIGINAL APPROVAL
2001-05-11
LATEST ACTION
2023-05-19
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

YASMIN · ReferencePrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28

Approval history

2023-05-19Labeling · Supplement 29 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 30 · standard — Label ↗AP
2017-08-09Labeling · Supplement 28 · standard — Label ↗AP
2016-03-08Manufacturing (CMC) · Supplement 26 · standardAP
2015-06-01Labeling · Supplement 23 · standard — Letter ↗AP
2014-11-26Manufacturing (CMC) · Supplement 24 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 25 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 20 · standardAP
2012-04-10Labeling · Supplement 22 · standard — Label ↗AP
2012-02-13Efficacy · Supplement 19 · standard — Letter ↗AP
2010-04-07Labeling · Supplement 17 · unknown — Label ↗AP
2003-05-09Efficacy · Supplement 5 · standard — Letter ↗AP
2002-08-08Manufacturing (CMC) · Supplement 6 · standardAP
2001-12-12Manufacturing (CMC) · Supplement 4 · standardAP
2001-11-30Manufacturing (CMC) · Supplement 2 · standardAP
2001-11-30Manufacturing (CMC) · Supplement 3 · standardAP
2001-11-26Manufacturing (CMC) · Supplement 1 · standardAP
2001-05-11Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP
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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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