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FDA Approval

ZAFEMY

CompanyBryant Ranch Prepack (DUNS: 171714327)

Effective Date

January 5, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Norelgestromin(150 ug in 1 d)

Ethinylestradiol(35 ug in 1 d)

Registrants (1)

Bryant Ranch Prepack

DUNS Number

171714327

Manufacturing Establishments (1)

Bryant Ranch Prepack

Labeler

Bryant Ranch Prepack

Registrant

Bryant Ranch Prepack

DUNS Number

171714327

Products (1)

ZAFEMY

NDC Product Code

72162-2220

Application Number

ANDA213950

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

January 5, 2024

Ingredients

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 d

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40Class: IACT

EthinylestradiolActive

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

POLYBUTENE (1400 MW)Inactive

Code: 1NA5AO9GH7Class: IACT

OLEYL ALCOHOLInactive

Code: 172F2WN8DVClass: IACT

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