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FDA Approval

norelgestromin and ethinyl estradiol

CompanyZydus Lifesciences Limited (DUNS: 918596198)

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)

Manufacturing Establishments (1)

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

DUNS Number

918596198

Products (1)

norelgestromin and ethinyl estradiol

NDC Product Code

70771-1777

Application Number

ANDA214594

Marketing Category

ANDA (C73584)

Route of Administration

TRANSDERMAL

Effective Date

September 16, 2023

Ingredients

NorelgestrominActive

Code: R0TAY3X631Class: ACTIBQuantity: 150 ug in 1 mg

EthinylestradiolActive

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

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

LAURYL LACTATEInactive

Code: G5SU0BFK7OClass: IACT

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