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FDA ANDA · ANDA070686

NORETHINDRONE AND ETHINYL ESTRADIOL

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA070686
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-29
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2022-04-29Labeling · Supplement 38 · standardAP
2022-04-22Labeling · Supplement 37 · standardAP
2002-06-26Manufacturing (CMC) · Supplement 16AP
2002-05-21Manufacturing (CMC) · Supplement 14AP
2002-05-08Labeling · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 13AP
2001-08-27Manufacturing (CMC) · Supplement 12AP
1997-05-01Labeling · Supplement 9AP
1993-11-04Labeling · Supplement 8AP
1993-08-10Manufacturing (CMC) · Supplement 7AP
1990-03-15Labeling · Supplement 6AP
1989-07-28Labeling · Supplement 5AP
1987-11-19Labeling · Supplement 4AP
1987-09-28Labeling · Supplement 3AP
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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