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LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2011-05-31

Drug application

FDA Application #

ANDA078834

Application type

Abbreviated New Drug Application (Generic)

Brand name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Generic name

ETHINYL ESTRADIOL AND LEVONORGESTREL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

DR REDDYS LABS SA

Manufacturer

Mayne Pharma Inc

First approval

2011-05-31

Source

Authoritative

Drugs@FDA application overview

Machine

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