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DROSPIRENONE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WATSON LABS · Approved 2011-11-28

Drug application

FDA Application #
ANDA078833
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
Marketing status
Prescription
Sponsor
WATSON LABS
Manufacturer
Teva Pharmaceuticals USA, Inc.
First approval
2011-11-28

Source

Authoritative
Drugs@FDA application overview
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