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PIMTREA

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2013-08-01

Drug application

FDA Application #

ANDA091247

Application type

Abbreviated New Drug Application (Generic)

Brand name

PIMTREA

Generic name

DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Active ingredients

DESOGESTREL; ETHINYL ESTRADIOL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

NOVAST LABS

Manufacturer

Mayne Pharma Inc.

First approval

2013-08-01

Source

Authoritative

Drugs@FDA application overview

Machine

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