Climara Pro
These highlights do not include all the information needed to use CLIMARA PRO safely and effectively. See full prescribing information for CLIMARA PRO. Initial U.S. Approval: 1975
Approved
Approval ID
184d3092-7fc6-4375-816b-1ab06bb99cfd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estradiol and Levonorgestrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-491
Application NumberNDA021258
Product Classification
M
Marketing Category
C73594
G
Generic Name
Estradiol and Levonorgestrel
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateNovember 1, 2017
FDA Product Classification
INGREDIENTS (2)
LEVONORGESTRELActive
Quantity: 0.015 mg in 1 d
Code: 5W7SIA7YZW
Classification: ACTIB
ESTRADIOLActive
Quantity: 0.045 mg in 1 d
Code: 4TI98Z838E
Classification: ACTIB