Dapsone
DAPSONE Tablets, USP 25 mg & 100 mg
Approved
Approval ID
d97e6985-b508-43c0-8c1f-6dfe9cc8a528
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2817
Application NumberANDA086841
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification
INGREDIENTS (5)
DAPSONEActive
Quantity: 25 mg in 1 1
Code: 8W5C518302
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Dapsone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3801
Application NumberANDA086842
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2011
FDA Product Classification
INGREDIENTS (5)
DAPSONEActive
Quantity: 100 mg in 1 1
Code: 8W5C518302
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT