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DROSPIRENONE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS · Approved 2020-01-24

Drug application

FDA Application #

ANDA213034

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

HETERO LABS

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2020-01-24

Source

Authoritative

Drugs@FDA application overview

Machine

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