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DROSPIRENONE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NAARI PTE · Approved 2016-11-22

Drug application

FDA Application #

ANDA207245

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

NAARI PTE

Manufacturer

Apotex Corp.

First approval

2016-11-22

Source

Authoritative

Drugs@FDA application overview

Machine

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