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FDA Approval

XULANE

CompanyMylan Pharmaceuticals Inc. (DUNS: 059295980)

Effective Date

March 4, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Norelgestromin(150 ug in 1 d)

Ethinylestradiol(35 ug in 1 d)

Products (1)

XULANE

NDC Product Code

0378-3340

Application Number

ANDA200910

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

February 4, 2021

Ingredients

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 d

EthinylestradiolActive

Code: 423D2T571UClass: ACTIBQuantity: 35 ug in 1 d

MINERAL OILInactive

Code: T5L8T28FGPClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

OLEYL ALCOHOLInactive

Code: 172F2WN8DVClass: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40Class: IACT

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