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FDA ANDA · ANDA091634
ALYACEN 1/35
norethindrone and ethinyl estradiol
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA091634
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-19
LATEST ACTION
2020-07-06
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALYACEN 1/35Prescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2020-07-06Labeling · Supplement 6 · standardAP
2020-07-06Labeling · Supplement 5 · standardAP
2015-05-16Labeling · Supplement 3 · standardAP
2013-03-29Labeling · Supplement 2 · standardAP
2012-07-31Labeling · Supplement 1AP
2012-01-19Not Applicable · OriginalAP
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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