Sulfasalazine
SULFASALAZINE TABLETS, USP
Approved
Approval ID
2fc8c918-157c-4898-9b26-80d9ae2fc143
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-756
Application NumberANDA040349
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulfasalazine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2014
FDA Product Classification
INGREDIENTS (7)
SULFASALAZINEActive
Quantity: 500 mg in 1 1
Code: 3XC8GUZ6CB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT