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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Colazal (generic drugs available since 2007-12-28, discontinued: 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 disodiumANDA2023-03-29
colazalNDA authorized generic2019-06-21
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
Clinical Trials
53 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BurnsD002056T30.0111125
Dental pulp necrosisD003790K04.1314
SinusitisD012852EFO_0007486J32112
Periapical abscessD010482EFO_100120211
Chronic kidney failureD007676EFO_0003884N18.611
Arteriovenous fistulaD001164Q27.311
Surgical wound infectionD01353011
Type 2 diabetes mellitusD003924EFO_0001360E1111
Diabetic footD017719EFO_100145911
Type 1 diabetes mellitusD003922EFO_0001359E1011
Show 1 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sick sinus syndromeD012804EFO_0004275I49.5112
Systolic heart failureD054143EFO_1001207I50.2011
SyncopeD013575HP_0001279G90.0111
Heart blockD006327I45.8911
Cardiac arrhythmiasD001145EFO_0004269I49.911
EdemaD004487R60.9111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I50112
Skin neoplasmsD012878EFO_0004198C4411
Paranasal sinus diseasesD01025411
Allergic contact dermatitisD017449L2311
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Asymptomatic diseasesD05807011
MammaplastyD01646211
RegenerationD01203811
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gestational diabetesD016640HP_0009800O24.411
Hiv infectionsD015658EFO_0000764B2011
Herpes simplexD006561B0011
Breast neoplasmsD001943EFO_0003869C5011
Finger injuriesD00538311
Traumatic amputationD00067311
Infectious skin diseasesD01287411
Pituitary neoplasmsD01091111
Uterine ruptureD01459711
Premature birthD047928EFO_0003917O6011
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Epidemiology
Epidemiological information for investigational and approved indications
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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)
Image (chem structure or protein)
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
RxCUI18747
ChEMBL IDCHEMBL1201346
ChEBI ID267413
PubChem CID5362070
DrugBankDB01014
UNII IDP80AL8J7ZP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 690 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,674 adverse events reported
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