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
NDC Product Code70518-0185
Application NumberANDA085828
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameSulfasalazine
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