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HAILEY FE 1/20

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2017-11-21

Drug application

FDA Application #
ANDA206597
Application type
Abbreviated New Drug Application (Generic)
Brand name
HAILEY FE 1/20
Generic name
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Active ingredients
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Dosage form
TABLET
Route
ORAL-28
Marketing status
Prescription
Sponsor
GLENMARK PHARMS LTD
Manufacturer
Glenmark Pharmaceuticals Inc., USA
First approval
2017-11-21

Source

Authoritative
Drugs@FDA application overview
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