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FDA Approval

NuvaRing

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

February 9, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Etonogestrel(11.7 mg in 1 1)

Ethinylestradiol(2.7 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

NuvaRing

NDC Product Code

54868-4832

Application Number

NDA021187

Marketing Category

NDA (C73594)

Route of Administration

VAGINAL

Effective Date

February 9, 2012

Ingredients

EtonogestrelActive

Code: 304GTH6RNHClass: ACTIBQuantity: 11.7 mg in 1 1

EthinylestradiolActive

Code: 423D2T571UClass: ACTIMQuantity: 2.7 mg in 1 1

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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