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FDA ANDA · ANDA076393

NORETHINDRONE AND ETHINYL ESTRADIOL

Sponsor: WATSON LABS

APPLICATION
ANDA076393
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-04
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 8 · standardAP
2022-02-25Labeling · Supplement 7 · standardAP
2010-02-04OriginalAP
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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