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NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2016-04-22

Drug application

FDA Application #
ANDA208097
Application type
Abbreviated New Drug Application (Generic)
Brand name
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
Generic name
Norethindrone Acetate
Active ingredients
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
GLENMARK PHARMS LTD
First approval
2016-04-22

Source

Authoritative
Drugs@FDA application overview
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