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FDA Approval

Climara Pro

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

June 3, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Estradiol(4.4 mg in 1 1)

Levonorgestrel(1.39 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Climara Pro

NDC Product Code

54868-5570

Application Number

NDA021258

Marketing Category

NDA (C73594)

Route of Administration

TRANSDERMAL

Effective Date

December 15, 2010

Ingredients

EstradiolActive

Code: 4TI98Z838EClass: ACTIBQuantity: 4.4 mg in 1 1

LevonorgestrelActive

Code: 5W7SIA7YZWClass: ACTIBQuantity: 1.39 mg in 1 1

POVIDONEInactive

Code: FZ989GH94EClass: IACT

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