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ALYACEN 1/35

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2012-01-19

Drug application

FDA Application #

ANDA091634

Application type

Abbreviated New Drug Application (Generic)

Brand name

ALYACEN 1/35

Generic name

NORETHINDRONE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

GLENMARK PHARMS LTD

Manufacturer

Glenmark Pharmaceuticals Inc., USA

First approval

2012-01-19

Source

Authoritative

Drugs@FDA application overview

Machine

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