DAPSONE
Dapsone Tablets USP, 25 mg and 100 mg
Approved
Approval ID
57a47368-d1f6-4d61-a2ee-c5f1fe7ff690
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2019
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code70954-135
Application NumberANDA206505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DAPSONEActive
Quantity: 25 mg in 1 1
Code: 8W5C518302
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
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 Code70954-136
Application NumberANDA206505
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dapsone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (5)
DAPSONEActive
Quantity: 100 mg in 1 1
Code: 8W5C518302
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT