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FDA Approval

Climara Pro

CompanyBayer HealthCare Pharmaceuticals Inc. (DUNS: 005436809)

Effective Date

December 6, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levonorgestrel(0.015 mg in 1 d)

Estradiol(0.045 mg in 1 d)

Manufacturing Establishments (1)

Kindeva Drug Delivery L>P>

Labeler

Bayer HealthCare Pharmaceuticals Inc.

DUNS Number

128688199

Products (1)

Climara Pro

NDC Product Code

50419-491

Application Number

NDA021258

Marketing Category

NDA (C73594)

Route of Administration

TRANSDERMAL

Effective Date

November 1, 2017

Ingredients

LevonorgestrelActive

Code: 5W7SIA7YZWClass: ACTIBQuantity: 0.015 mg in 1 d

EstradiolActive

Code: 4TI98Z838EClass: ACTIBQuantity: 0.045 mg in 1 d

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