Active substance
Balsalazide
- US FDA 8
- US price lines 1
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| COLAZAL | 750MG | capsule · oral | VALEANT PHARMS INTL | Prescription | 18 Jul 2000 |
| BALSALAZIDE DISODIUM | 750MG | capsule · oral | HIKMA PHARMS | Prescription | 28 Dec 2007 |
| BALSALAZIDE DISODIUM | 750MG | capsule · oral | NOVITIUM PHARMA | Prescription | 28 Dec 2007 |
| BALSALAZIDE DISODIUM | 750MG | capsule · oral | APOTEX | Prescription | 28 Dec 2007 |
| BALSALAZIDE DISODIUM | 750MG | capsule · oral | ZYDUS LIFESCIENCES | Prescription | 8 Jun 2023 |
| BALSALAZIDE DISODIUM | 750MG | capsule · oral | CARNEGIE | Prescription | 3 Apr 2025 |
| GIAZO | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | VALEANT PHARMS INTL | Discontinued | 3 Feb 2012 |
| BALSALAZIDE DISODIUM | 1.1GM | tablet · oral | AARXION ANDA HLDING | Discontinued | 8 Sep 2015 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BALSALAZIDE DISODIUM 750 MG CP | $0.34426 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Balsalazide 750mg capsules | £30.42 | 130 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 1 Nov 2021 GIAZO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.