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FDA Approval

Etonogestrel and Ethinyl Estradiol Vaginal Ring

CompanyNorthstar Rx LLC (DUNS: 830546433)

Effective Date

July 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ethinylestradiol(0.015 mg in 1 d)

Etonogestrel(0.12 mg in 1 d)

Manufacturing Establishments (1)

Laboratorios León Farma, S.A.

Labeler

Northstar Rx LLC

DUNS Number

467782459

Products (1)

Etonogestrel and Ethinyl Estradiol Vaginal Ring

NDC Product Code

16714-029

Application Number

ANDA211157

Marketing Category

ANDA (C73584)

Route of Administration

VAGINAL

Effective Date

July 1, 2023

Ingredients

EthinylestradiolActive

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

Ethylene-Vinyl Acetate Copolymer (9% Vinylacetate)Inactive

Code: 4OKC630HS6Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

EtonogestrelActive

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

Ethylene-Vinyl Acetate Copolymer (28% Vinyl Acetate)Inactive

Code: 8ILA5X28VSClass: IACT

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