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LERIBANE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVAST LABS · Approved 2016-06-03

Drug application

FDA Application #

ANDA203435

Application type

Abbreviated New Drug Application (Generic)

Brand name

LERIBANE

Generic name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NOVAST LABS

Manufacturer

Nivagen Pharmaceuticals, Inc.

First approval

2016-06-03

Source

Authoritative

Drugs@FDA application overview

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