Calcipotriene
Calcipotriene Ointment, 0.005%
Approved
Approval ID
277d843a-0ea9-429d-813d-49ed72dafb64
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-4154
Application NumberANDA090633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcipotriene
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 3, 2019
FDA Product Classification
INGREDIENTS (9)
sodium phosphate, dibasic, dihydrateInactive
Code: 94255I6E2T
Classification: IACT
CalcipotrieneActive
Quantity: 0.05 mg in 1 g
Code: 143NQ3779B
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
.alpha.-tocopherolInactive
Code: H4N855PNZ1
Classification: IACT
steareth-2Inactive
Code: V56DFE46J5
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT