Calcipotriene
Calcipotriene Ointment USP, 0.005%
Approved
Approval ID
1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcipotriene
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-310
Application NumberANDA090633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcipotriene
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 17, 2020
FDA Product Classification
INGREDIENTS (9)
CALCIPOTRIENEActive
Quantity: 50 ug in 1 g
Code: 143NQ3779B
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT