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FDA ANDA · ANDA202085

DESOGESTREL AND ETHINYL ESTRADIOL

Sponsor: XIROMED

APPLICATION
ANDA202085
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-20
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DESOGESTREL AND ETHINYL ESTRADIOLDiscontinued
DESOGESTREL 0.15MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 6 · standardAP
2017-08-09Labeling · Supplement 3 · standardAP
2016-05-26Labeling · Supplement 1 · standardAP
2015-05-20Not Applicable · OriginalAP
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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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