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FDA ANDA · ANDA070685

NORETHINDRONE AND ETHINYL ESTRADIOL

Sponsor: WATSON PHARMS TEVA

APPLICATION
ANDA070685
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-29
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORETHINDRONE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-21

Approval history

2022-04-29Labeling · Supplement 35 · standardAP
2017-08-09Labeling · Supplement 34 · standardAP
2002-12-13Manufacturing (CMC) · Supplement 16AP
2002-12-13Manufacturing (CMC) · Supplement 17AP
2002-06-26Manufacturing (CMC) · Supplement 15AP
2002-05-21Manufacturing (CMC) · Supplement 13AP
2002-05-08Labeling · Supplement 9AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-01-29Manufacturing (CMC) · Supplement 10AP
1997-05-01Labeling · Supplement 8AP
1993-11-04Labeling · Supplement 36AP
1993-11-04Labeling · Supplement 7AP
1990-03-15Labeling · Supplement 6AP
1989-07-28Labeling · Supplement 5AP
1987-11-19Labeling · Supplement 3AP
1987-11-19Labeling · Supplement 4AP
1987-02-25Labeling · Supplement 1AP
1987-01-29OriginalAP
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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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