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AFIRMELLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2016-11-14

Drug application

FDA Application #

ANDA206886

Application type

Abbreviated New Drug Application (Generic)

Brand name

AFIRMELLE

Generic name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA

Manufacturer

Afaxys Pharma, LLC

First approval

2016-11-14

Source

Authoritative

Drugs@FDA application overview

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