Colazal
These highlights do not include all the information needed to use COLAZAL safely and effectively. See full prescribing information for COLAZAL. COLAZAL® (balsalazide disodium) capsules, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
22f41e83-b9fb-4c9e-8cc3-f457034191a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Salix Pharmaceuticals, Inc
DUNS: 793108036
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
balsalazide disodium
PRODUCT DETAILS
NDC Product Code65649-101
Application NumberNDA020610
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 2, 2023
Generic Namebalsalazide disodium
INGREDIENTS (3)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BALSALAZIDE DISODIUMActive
Quantity: 750 mg in 1 1
Code: 1XL6BJI034
Classification: ACTIB