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XULANE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN TECHNOLOGIES · Approved 2014-04-16

Drug application

FDA Application #

ANDA200910

Application type

Abbreviated New Drug Application (Generic)

Brand name

XULANE

Generic name

NORELGESTROMIN AND ETHINYL ESTRADIOL

Active ingredients

ETHINYL ESTRADIOL; NORELGESTROMIN

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

Marketing status

Prescription

Sponsor

MYLAN TECHNOLOGIES

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2014-04-16

Source

Authoritative

Drugs@FDA application overview

Machine

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