Climara Pro
Climara Pro
Approved
Approval ID
eabc0fb3-da2a-482f-83a7-99b1e823a150
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5570
Application NumberNDA021258
Product Classification
M
Marketing Category
C73594
G
Generic Name
Estradiol and Levonorgestrel
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2010
FDA Product Classification
INGREDIENTS (3)
ESTRADIOLActive
Quantity: 4.4 mg in 1 1
Code: 4TI98Z838E
Classification: ACTIB
LEVONORGESTRELActive
Quantity: 1.39 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT