Sulfasalazine
Sulfasalazine Tablets, USP Rx only
Approved
Approval ID
9d6cf030-aaed-4427-bceb-b6a04af70bee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulfasalazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70518-0185
Application NumberANDA085828
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfasalazine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB