FDA — authorised 29 December 2025
- Application: ANDA202327
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 sitagliptin (MK0431) in United States
FDA authorised sitagliptin (MK0431) on 29 December 2025
Marketing authorisations
FDA — authorised 14 January 2026
- Application: ANDA202387
- Marketing authorisation holder: SANDOZ
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214693
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA208186
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214700
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA202473
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA204591
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA215155
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA214784
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211073
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA202487
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: SITAGLIPTIN PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA202365
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Other Diabetes approved in United States
Frequently asked questions
Is sitagliptin (MK0431) approved in United States?
Yes. FDA authorised it on 29 December 2025; FDA authorised it on 14 January 2026; FDA has authorised it.
Who is the marketing authorisation holder for sitagliptin (MK0431) in United States?
WATSON LABS INC holds the US marketing authorisation.