Sulfasalazine
Sulfasalazine Tablets, USP
Approved
Approval ID
76b532a3-e7ca-4929-8c51-c0f66e0806a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-6936
Application NumberNDA007073
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateOctober 31, 2022
Generic NameSulfasalazine
INGREDIENTS (8)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
ZEA MAYS (CORN) STARCHInactive
Code: O8232NY3SJ
Classification: IACT