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FDA Approval

norelgestromin and ethinyl estradiol

CompanyZydus Pharmaceuticals USA Inc. (DUNS: 156861945)

Effective Date

September 16, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Norelgestromin(150 ug in 1 mg)

Ethinylestradiol(35 ug in 1 mg)

Registrants (1)

ZYDUS NOVELTECH INC, USA

DUNS Number

801012530

Manufacturing Establishments (1)

Zydus Lifesciences Limited

Labeler

Zydus Pharmaceuticals USA Inc.

Registrant

ZYDUS NOVELTECH INC, USA

DUNS Number

918596198

Products (1)

norelgestromin and ethinyl estradiol

NDC Product Code

70710-1190

Application Number

ANDA214594

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

September 16, 2023

Ingredients

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 mg

LAURYL LACTATEInactive

Code: G5SU0BFK7OClass: IACT

EthinylestradiolActive

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

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