calcipotriene and betamethasone dipropionate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2006
Approved
Approval ID
1359f4b2-60c9-42c9-8b25-9ef955ffeae5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
calcipotriene and betamethasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-889
Application NumberANDA212367
Product Classification
M
Marketing Category
C73584
G
Generic Name
calcipotriene and betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (6)
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: .5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CALCIPOTRIENE MONOHYDRATEActive
Quantity: 50 ug in 1 g
Code: S7499TYY6G
Classification: ACTIM