FDA — authorised 24 December 1987
- Application: NDA019618
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Status: supplemented
🇺🇸 MESALAMINE in United States
FDA authorised MESALAMINE on 24 December 1987 · 30,717 US adverse-event reports
Marketing authorisations
FDA — authorised 25 January 2019
- Application: ANDA211858
- Marketing authorisation holder: SUN PHARM
- Status: supplemented
FDA — authorised 20 November 2019
- Application: ANDA207271
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 19 March 2020
- Application: ANDA213377
- Marketing authorisation holder: ANNORA PHARMA
- Status: supplemented
FDA — authorised 11 May 2022
- Application: ANDA214585
- Marketing authorisation holder: SUN PHARM
- Status: supplemented
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 30,717
Most-reported reactions
- Off Label Use — 6,196 reports (20.17%)
- Drug Ineffective — 4,311 reports (14.03%)
- Colitis Ulcerative — 4,278 reports (13.93%)
- Condition Aggravated — 3,268 reports (10.64%)
- Diarrhoea — 2,540 reports (8.27%)
- Haematochezia — 2,328 reports (7.58%)
- Fatigue — 2,098 reports (6.83%)
- Abdominal Pain — 2,088 reports (6.8%)
- Weight Decreased — 1,817 reports (5.92%)
- Nausea — 1,793 reports (5.84%)
MESALAMINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is MESALAMINE approved in United States?
Yes. FDA authorised it on 24 December 1987; FDA authorised it on 25 January 2019; FDA authorised it on 20 November 2019.
Who is the marketing authorisation holder for MESALAMINE in United States?
MYLAN SPECIALITY LP holds the US marketing authorisation.