Azulfidine
Azulfidine sulfasalazine tablets, USP
Approved
Approval ID
ddbe69f3-bd55-45f3-a64f-f60226c744c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2022
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
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 Code0013-0101
Application NumberNDA007073
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 26, 2022
Generic NameSulfasalazine
INGREDIENTS (5)
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT