Dapsone
DAPSONETablets, USP25 mg & 100 mg
Approved
Approval ID
229af266-d901-43e2-828a-4931d1124ea3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2020
Manufacturers
FDA
Seton Pharmaceuticals
DUNS: 828898002
Products 2
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 Code13925-505
Application NumberANDA086842
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2016
FDA Product Classification
INGREDIENTS (5)
DapsoneActive
Quantity: 100 mg in 1 1
Code: 8W5C518302
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Dapsone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13925-504
Application NumberANDA086841
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2016
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DAPSONEActive
Quantity: 25 mg in 1 1
Code: 8W5C518302
Classification: ACTIB