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Drug ReportsBalsalazide
Balsalazide
Balsalazide, Colazal (balsalazide) is a small molecule pharmaceutical. Balsalazide was first approved as Colazal on 2000-07-18. It is used to treat ulcerative colitis in the USA.
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Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
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YTD
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2Y
5Y
Max
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Balsalazide, Colazal (discontinued: Balsalazide, Giazo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Balsalazide disodium
Tradename
Company
Number
Date
Products
COLAZALBausch Health CompaniesN-020610 RX2000-07-18
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
balsalazide disodiumANDA2025-01-02
colazalNew Drug Application2023-11-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ulcerative colitisEFO_0000729D003093K51
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Balsalazide Disodium, Giazo, Valeant Pharms Intl
84972562031-06-23U-1229
91926162026-08-02U-1229
Balsalazide Disodium, Colazal, Valeant Pharms Intl
74528722026-08-24U-141, U-1229
76258842026-08-24U-141, U-1229
ATC Codes
A: Alimentary tract and metabolism drugs
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07E: Intestinal antiinflammatory agents
A07EC: Aminosalicylic acid and similar agents
A07EC04: Balsalazide
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameBalsalazide
INNbalsalazide
Description
Balsalazide is an anti-inflammatory drug used in the treatment of inflammatory bowel disease. It is sold under the brand names Giazo, Colazal in the US and Colazide in the UK. It is also sold in generic form in the US by several generic manufacturers.
Classification
Small molecule
Drug classanti-inflammatory agents (salicylic acid derivatives)
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCNC(=O)c1ccc(/N=N/c2ccc(O)c(C(=O)O)c2)cc1
Identifiers
PDB
CAS-ID80573-04-2
RxCUI
ChEMBL IDCHEMBL1201346
ChEBI ID267413
PubChem CID5362070
DrugBankDB01014
UNII IDP80AL8J7ZP (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Balsalazide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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