Calcipotriene
CALCIPOTRIENE TOPICAL SOLUTION 0.005% (Scalp Solution)
Approved
Approval ID
fff63bc7-6b92-4080-9a11-017124d95162
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2020
Manufacturers
FDA
Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code0168-0400
Application NumberANDA078305
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcipotriene
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2018
FDA Product Classification
INGREDIENTS (7)
calcipotrieneActive
Quantity: 0.05 mg in 1 mL
Code: 143NQ3779B
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
isopropyl alcoholInactive
Quantity: 0.51 mL in 1 mL
Code: ND2M416302
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 WAMW)Inactive
Code: U3JF91U133
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT