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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65649-101
Application NumberNDA020610
Product Classification
M
Marketing Category
C73594
G
Generic Name
balsalazide disodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2023
FDA Product Classification
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