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FDA ANDA · ANDA201095

LEVONORGESTREL AND ETHINYL ESTRADIOL

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA201095
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-08
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2022-04-29Labeling · Supplement 3 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2014-12-08Not 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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