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SIMPESSE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2017-04-07

Drug application

FDA Application #

ANDA206851

Application type

Abbreviated New Drug Application (Generic)

Brand name

SIMPESSE

Generic name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA

Manufacturer

Aurobindo Pharma Limited

First approval

2017-04-07

Source

Authoritative

Drugs@FDA application overview

Machine

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