Dapsone
These highlights do not include all the information needed to use DAPSONE GEL safely and effectively. See full prescribing information for DAPSONE GEL. DAPSONE Gel, for topical useInitial U.S. Approval: 1955
Approved
Approval ID
2811f7de-13bf-45cd-8413-5b04d11f40ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dapsone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-663
Application NumberANDA215718
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (7)
DAPSONEActive
Quantity: 75 mg in 1 g
Code: 8W5C518302
Classification: ACTIB
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)Inactive
Code: 5F4963KLHS
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT