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FDA Approval

Etonogestrel and Ethinyl Estradiol Vaginal

CompanyAvKARE (DUNS: 796560394)

Effective Date

September 21, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Etonogestrel(0.12 mg in 1 d)

Ethinylestradiol(0.015 mg in 1 d)

Products (1)

Etonogestrel and Ethinyl Estradiol Vaginal

NDC Product Code

42291-478

Application Number

ANDA211157

Marketing Category

ANDA (C73584)

Route of Administration

VAGINAL

Effective Date

September 21, 2023

Ingredients

ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE)Inactive

Code: 8ILA5X28VSClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ETHYLENE-VINYL ACETATE COPOLYMER (9% VINYLACETATE)Inactive

Code: 4OKC630HS6Class: IACT

EtonogestrelActive

Code: 304GTH6RNHClass: ACTIBQuantity: 0.12 mg in 1 d

EthinylestradiolActive

Code: 423D2T571UClass: ACTIBQuantity: 0.015 mg in 1 d

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