Calcipotriene
Calcipotriene Topical Solution, 0.005% (Scalp Solution)
Approved
Approval ID
53c9942a-e861-493f-95c2-53446bc5f06d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
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 Code50383-732
Application NumberANDA077579
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcipotriene
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (7)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CALCIPOTRIENE HYDRATEActive
Quantity: 0.05 mg in 1 mL
Code: S7499TYY6G
Classification: ACTIM