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FDA ANDA · ANDA076916

DESOGESTREL AND ETHINYL ESTRADIOL

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA076916
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-29
LATEST ACTION
2024-06-10
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DESOGESTREL AND ETHINYL ESTRADIOLDiscontinued
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28

Approval history

2024-06-10Labeling · Supplement 14 · standardAP
2022-04-29Labeling · Supplement 13 · standardAP
2017-08-09Labeling · Supplement 12 · standardAP
2013-03-29Labeling · Supplement 6 · standardAP
2008-12-29OriginalAP
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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