DAPSONE
These highlights do not include all the information needed to use dapsone gel, 5% safely and effectively. See full prescribing information for dapsone gel, 5%. Dapsone gel, 5%, for topical use Initial U.S. Approval: 1955
Approved
Approval ID
8dbe1a41-6d9d-414f-aa9c-09bd95857e2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2018
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
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 Code60758-670
Application NumberNDA021794
Product Classification
M
Marketing Category
C73605
G
Generic Name
dapsone
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 24, 2023
FDA Product Classification
INGREDIENTS (6)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
dapsoneActive
Quantity: 50 mg in 1 g
Code: 8W5C518302
Classification: ACTIB
DIETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: A1A1I8X02B
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT