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FDA ANDA · ANDA071043

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

Sponsor: WATSON LABS

APPLICATION
ANDA071043
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-01
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)Discontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 28 · standardAP
2017-08-09Labeling · Supplement 27 · standardAP
2002-11-05Manufacturing (CMC) · Supplement 12AP
2002-11-05Manufacturing (CMC) · Supplement 13AP
2002-06-26Manufacturing (CMC) · Supplement 11AP
2002-05-21Manufacturing (CMC) · Supplement 9AP
2002-05-08Labeling · Supplement 6AP
2002-01-10Manufacturing (CMC) · Supplement 8AP
2001-10-31Manufacturing (CMC) · Supplement 7AP
1997-05-01Labeling · Supplement 5AP
1993-11-04Labeling · Supplement 4AP
1993-08-10Manufacturing (CMC) · Supplement 3AP
1990-03-15Labeling · Supplement 2AP
1988-04-01OriginalAP
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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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