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FDA Approval

ZAFEMY

CompanyAvKARE (DUNS: 796560394)

Effective Date

May 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Norelgestromin(150 ug in 1 d)

Ethinylestradiol(35 ug in 1 d)

Products (1)

ZAFEMY

NDC Product Code

42291-930

Application Number

ANDA213950

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

May 15, 2023

Ingredients

POLYBUTENE (1400 MW)Inactive

Code: 1NA5AO9GH7Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40Class: IACT

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 d

OLEYL ALCOHOLInactive

Code: 172F2WN8DVClass: IACT

EthinylestradiolActive

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

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