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FDA ANDA · ANDA077527

DROSPIRENONE AND ETHINYL ESTRADIOL

Sponsor: BARR

APPLICATION
ANDA077527
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-09
LATEST ACTION
2024-02-05
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DROSPIRENONE AND ETHINYL ESTRADIOLDiscontinued
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28

Approval history

2024-02-05Labeling · Supplement 4 · standardAP
2015-10-09Labeling · Supplement 3 · standardAP
2015-10-09Labeling · Supplement 2 · standardAP
2008-05-09Original — 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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