011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
Approved
Approval ID
a97a5200-06de-1fad-e053-2a95a90a996d
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.
011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72934-1211
Product Classification
G
Generic Name
011503 DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 2, 2020
FDA Product Classification
INGREDIENTS (3)
NIACINAMIDEActive
Quantity: 2 g in 100 g
Code: 25X51I8RD4
Classification: ACTIB
SPIRONOLACTONEActive
Quantity: 5 g in 100 g
Code: 27O7W4T232
Classification: ACTIB
DAPSONEActive
Quantity: 6 g in 100 g
Code: 8W5C518302
Classification: ACTIB