TACLONEX
These highlights do not include all the information needed to use TACLONEX Topical Suspension safely and effectively. See full prescribing information for TACLONEX Topical Suspension. TACLONEX (calcipotriene and betamethasone dipropionate) topical suspension Initial U.S. Approval: 2006
Approved
Approval ID
757c914f-dd8d-43cc-a973-212d591af4af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2017
Manufacturers
FDA
LEO Pharma Inc.
DUNS: 832692615
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 Code50222-501
Application NumberNDA022185
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcipotriene and betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2017
FDA Product Classification
INGREDIENTS (7)
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
PPG-11 STEARYL ETHERInactive
Code: S4G2J0Y0LG
Classification: IACT
CALCIPOTRIENE HYDRATEActive
Quantity: 50 ug in 1 g
Code: S7499TYY6G
Classification: ACTIM