Sulfasalazine
Sulfasalazine Tablets, USP
Approved
Approval ID
a5a23c68-f5bd-42dd-b72c-0641659bae46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-495
Application NumberNDA007073
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sulfasalazine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2014
FDA Product Classification
INGREDIENTS (4)
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