← FDA DRUG APPROVALS

FDA NDA · NDA021355

ANGELIQ

drospirenone and estradiol

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021355
TYPE
NDA
ORIGINAL APPROVAL
2005-09-28
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ANGELIQ · ReferencePrescription
DROSPIRENONE 0.5MG, ESTRADIOL 1MG · TABLET · ORAL
ANGELIQ · ReferencePrescription
DROSPIRENONE 0.25MG, ESTRADIOL 0.5MG · TABLET · ORAL

Approval history

2024-02-15Labeling · Supplement 12 · standard — Letter ↗AP
2023-10-02Labeling · Supplement 10 · standard — Letter ↗AP
2023-10-02Labeling · Supplement 9 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 8 · standard — Label ↗AP
2015-06-30Labeling · Supplement 6 · standard — Label ↗AP
2015-01-26Manufacturing (CMC) · Supplement 5 · standardAP
2012-02-29Labeling · Supplement 2 · standard — Letter ↗AP
2012-02-29Efficacy · Supplement 3 · standard — Letter ↗AP
2005-09-28Type 4 - New Combination · Original · standard — Label ↗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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