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DROSPIRENONE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK PHARMS LTD · Approved 2016-03-25

Drug application

FDA Application #

ANDA204848

Application type

Abbreviated New Drug Application (Generic)

Brand name

DROSPIRENONE AND ETHINYL ESTRADIOL

Generic name

DROSPIRENONE AND ETHINYL ESTRADIOL

Active ingredients

DROSPIRENONE; ETHINYL ESTRADIOL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

GLENMARK PHARMS LTD

Manufacturer

Glenmark Pharmaceuticals Inc., USA

First approval

2016-03-25

Source

Authoritative

Drugs@FDA application overview

Machine

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