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LEVONORGESTREL AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS · Approved 2023-02-13

Drug application

FDA Application #

ANDA212298

Application type

Abbreviated New Drug Application (Generic)

Brand name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Generic name

LEVONORGETSREL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

HETERO LABS

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2023-02-13

Source

Authoritative

Drugs@FDA application overview

Machine

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