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BALZIVA-28

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BARR · Approved 2004-04-22

Drug application

FDA Application #

ANDA076238

Application type

Abbreviated New Drug Application (Generic)

Brand name

BALZIVA-28

Generic name

NORETHINDRONE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

BARR

Manufacturer

Teva Pharmaceuticals USA, Inc.

First approval

2004-04-22

Source

Authoritative

Drugs@FDA application overview

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