FDA — authorised 24 December 1987
- Application: NDA019618
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: SFROWASA
- Indication: ENEMA — RECTAL
- Status: approved
🇺🇸 Asacol (mesalamine) in United States
FDA authorised Asacol (mesalamine) on 24 December 1987 · 6 US adverse-event reports
Marketing authorisations
FDA — authorised 17 September 2004
- Application: ANDA076751
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 30 September 2004
- Application: ANDA076841
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 29 May 2008
- Application: NDA021830
- Marketing authorisation holder: ABBVIE
- Local brand name: ASACOL HD
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 31 October 2008
- Application: NDA022301
- Marketing authorisation holder: SALIX
- Local brand name: APRISO
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 November 2015
- Application: ANDA204354
- Marketing authorisation holder: QUAGEN
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA091640
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA203286
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 March 2018
- Application: ANDA203817
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 20 November 2018
- Application: ANDA203574
- Marketing authorisation holder: MYLAN
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 January 2019
- Application: ANDA211858
- Marketing authorisation holder: SUN PHARM
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA207448
- Marketing authorisation holder: RISING
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 9 May 2019
- Application: ANDA207873
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MESALAMINE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 June 2019
- Application: ANDA208362
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA207271
- Marketing authorisation holder: MYLAN
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 January 2020
- Application: ANDA210509
- Marketing authorisation holder: AMNEAL
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 February 2020
- Application: ANDA208953
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 19 March 2020
- Application: ANDA213377
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 14 August 2020
- Application: ANDA205654
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 15 July 2021
- Application: ANDA214242
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 August 2021
- Application: ANDA208954
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 May 2022
- Application: ANDA209970
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 May 2022
- Application: ANDA214585
- Marketing authorisation holder: SUN PHARM
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 2022
- Application: ANDA216967
- Marketing authorisation holder: ALEMBIC
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 March 2023
- Application: ANDA214477
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 May 2023
- Application: ANDA217337
- Marketing authorisation holder: SINOTHERAPEUTICS INC
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 May 2023
- Application: ANDA216941
- Marketing authorisation holder: ENCUBE
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 6 June 2023
- Application: ANDA217533
- Marketing authorisation holder: AMTA
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 February 2024
- Application: ANDA216334
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA213191
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA218410
- Marketing authorisation holder: NOVAST LABS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA219028
- Marketing authorisation holder: RISING
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 16 April 2025
- Application: ANDA215269
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 10 March 2026
- Application: ANDA219997
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 March 2026
- Application: ANDA220016
- Marketing authorisation holder: KLM LABS PVT
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- 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: 22 April 2025 – 22 April 2026
- Total reports: 6
Most-reported reactions
- Adverse Event — 1 report (16.67%)
- Anaemia — 1 report (16.67%)
- Aortic Valve Disease — 1 report (16.67%)
- Hyperaesthesia — 1 report (16.67%)
- Lymphocyte Count Decreased — 1 report (16.67%)
- Pain — 1 report (16.67%)
Frequently asked questions
Is Asacol (mesalamine) approved in United States?
Yes. FDA authorised it on 24 December 1987; FDA authorised it on 17 September 2004; FDA authorised it on 30 September 2004.
Who is the marketing authorisation holder for Asacol (mesalamine) in United States?
MYLAN SPECIALITY LP holds the US marketing authorisation.