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FDA ANDA · ANDA090538

BRIELLYN

norethindrone and ethinyl estradiol

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA090538
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-22
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BRIELLYNPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 6 · standardAP
2017-08-09Labeling · Supplement 3 · standardAP
2014-02-25Labeling · Supplement 2 · standardAP
2011-03-22OriginalAP
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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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