011504 DAPSONE 8.5% / NIACINAMIDE 4%
011504 DAPSONE 8.5% / NIACINAMIDE 4%
Approved
Approval ID
a97aeb21-4efc-3d91-e053-2995a90a2298
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2020
Manufacturers
FDA
Sincerus Florida, LLC
DUNS: 080105003
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
011504 DAPSONE 8.5% / NIACINAMIDE 4%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72934-1212
Product Classification
G
Generic Name
011504 DAPSONE 8.5% / NIACINAMIDE 4%
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 2, 2020
FDA Product Classification
INGREDIENTS (2)
NIACINAMIDEActive
Quantity: 4 g in 100 g
Code: 25X51I8RD4
Classification: ACTIB
DAPSONEActive
Quantity: 8.5 g in 100 g
Code: 8W5C518302
Classification: ACTIB