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FDA Approval

Norelgestromin and Ethinly Estradiol

CompanyAmneal Pharmaceuticals NY LLC (DUNS: 123797875)

Effective Date

March 30, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Norelgestromin(150 ug in 1 d)

Ethinylestradiol(35 ug in 1 d)

Manufacturing Establishments (1)

Amneal Pharmaceuticals, LLC

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

053542455

Products (1)

Norelgestromin and Ethinly Estradiol

NDC Product Code

69238-1521

Application Number

ANDA213950

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

December 30, 2023

Ingredients

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 d

EthinylestradiolActive

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

POLYBUTENE (1400 MW)Inactive

Code: 1NA5AO9GH7Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

DIPROPYLENE GLYCOLInactive

Code: E107L85C40Class: IACT

OLEYL ALCOHOLInactive

Code: 172F2WN8DVClass: IACT

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