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NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BARR LABS INC · Approved 2009-11-06

Drug application

FDA Application #

ANDA076221

Application type

Abbreviated New Drug Application (Generic)

Brand name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Generic name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

BARR LABS INC

Manufacturer

Teva Pharmaceuticals USA, Inc.

First approval

2009-11-06

Source

Authoritative

Drugs@FDA application overview

Machine

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