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FDA ANDA · ANDA071042

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

Sponsor: WATSON LABS

APPLICATION
ANDA071042
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-24
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)Discontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 5 · standardAP
2017-08-09Labeling · Supplement 4 · standardAP
2002-05-21Manufacturing (CMC) · Supplement 3AP
1997-05-01Labeling · Supplement 2AP
1993-08-10Manufacturing (CMC) · Supplement 1AP
1991-09-24OriginalAP
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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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