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FDA ANDA · ANDA075406

OGESTREL 0.5/50-21

Sponsor: WATSON LABS

APPLICATION
ANDA075406
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-15
LATEST ACTION
2022-04-29
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OGESTREL 0.5/50-21Discontinued
ETHINYL ESTRADIOL 0.05MG, NORGESTREL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
OGESTREL 0.5/50-28Discontinued
ETHINYL ESTRADIOL 0.05MG, NORGESTREL 0.5MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 26 · standardAP
2017-08-09Labeling · Supplement 24 · standardAP
2017-07-19Labeling · Supplement 23 · standardAP
2008-12-04Labeling · Supplement 16 — Label ↗AP
2006-10-04Labeling · Supplement 11AP
1999-12-15Original — 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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