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
NDC Product Code60758-670
Application NumberNDA021794
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateApril 24, 2023
Generic Namedapsone
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