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ENSKYCE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LTD · Approved 2013-03-07

Drug application

FDA Application #

ANDA201887

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENSKYCE

Generic name

DESOGESTREL AND ETHINYL ESTRADIOL

Active ingredients

DESOGESTREL; ETHINYL ESTRADIOL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

LUPIN LTD

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2013-03-07

Source

Authoritative

Drugs@FDA application overview

Machine

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