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FDA ANDA · ANDA091636

ALYACEN 7/7/7

norethindrone and ethinyl estradiol

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA091636
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-19
LATEST ACTION
2020-07-06
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ALYACEN 777Prescription
NORETHINDRONE 1MG, ETHINYL ESTRADIOL 0.035MG · TABLET · ORAL
ALYACEN 7/7/7Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-28
ALYACEN 777Prescription
NORETHINDRONE 0.75MG, ETHINYL ESTRADIOL 0.035MG · TABLET · ORAL

Approval history

2020-07-06Labeling · Supplement 4 · standardAP
2020-07-06Labeling · Supplement 5 · standardAP
2015-05-16Labeling · Supplement 3 · standardAP
2013-03-29Labeling · Supplement 2 · standardAP
2012-06-28Labeling · Supplement 1AP
2012-01-19Not Applicable · OriginalAP
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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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