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FDA Approval

NuvaRing

CompanyCentral Texas Community Health Centers (DUNS: 079674019)

Effective Date

February 5, 2016

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Etonogestrel(0.12 mg in 1 d)

Ethinylestradiol(0.015 mg in 1 d)

Manufacturing Establishments (1)

Central Texas Community Health Centers

Labeler

Central Texas Community Health Centers

DUNS Number

079674019

Products (1)

NuvaRing

NDC Product Code

76413-131

Application Number

NDA021187

Marketing Category

NDA (C73594)

Route of Administration

VAGINAL

Effective Date

February 5, 2016

Ingredients

EtonogestrelActive

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

EthinylestradiolActive

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

ethylene-vinyl acetate copolymer (28% vinyl acetate)Inactive

Code: 8ILA5X28VSClass: IACT

ethylene-vinyl acetate copolymer (9% vinylacetate)Inactive

Code: 4OKC630HS6Class: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

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