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LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2017-12-14

Drug application

FDA Application #

ANDA205131

Application type

Abbreviated New Drug Application (Generic)

Brand name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Generic name

LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; LEVONORGESTREL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

XIROMED

Manufacturer

Xiromed, LLC.

First approval

2017-12-14

Source

Authoritative

Drugs@FDA application overview

Machine

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