FDA — authorised 14 July 1994
- Application: NDA018333
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 Carafate in United States
FDA authorised Carafate on 14 July 1994
Marketing authorisations
FDA — authorised 29 March 1996
- Application: ANDA070848
- Marketing authorisation holder: TEVA
- Local brand name: SUCRALFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 1998
- Application: ANDA074415
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SUCRALFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2019
- Application: ANDA209356
- Marketing authorisation holder: AMNEAL
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 March 2022
- Application: ANDA211884
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA215576
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: SUCRALFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2022
- Application: ANDA212913
- Marketing authorisation holder: MYLAN
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 May 2023
- Application: ANDA215705
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: SUCRALFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2024
- Application: ANDA213549
- Marketing authorisation holder: PD PARTNERS
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 March 2024
- Application: ANDA216726
- Marketing authorisation holder: ABON PHARMS LLC
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 May 2024
- Application: ANDA216474
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 July 2024
- Application: ANDA212769
- Marketing authorisation holder: HIKMA
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 13 November 2024
- Application: ANDA217126
- Marketing authorisation holder: COSETTE
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA211780
- Marketing authorisation holder: PADAGIS US
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 January 2026
- Application: ANDA212141
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: SUCRALFATE
- Indication: SUSPENSION — ORAL
- Status: approved
Carafate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Carafate approved in United States?
Yes. FDA authorised it on 14 July 1994; FDA authorised it on 29 March 1996; FDA authorised it on 8 June 1998.
Who is the marketing authorisation holder for Carafate in United States?
ABBVIE holds the US marketing authorisation.