FDA — authorised 7 July 2022
- Application: ANDA212198
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE in United States
FDA authorised EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 7 July 2022
Marketing authorisations
FDA
- Application: ANDA212362
- Marketing authorisation holder: MSN LABS PVT LTD
- Local brand name: EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA212373
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213654
- Marketing authorisation holder: LUPIN LTD
- Local brand name: EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA220511
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA212243
- Marketing authorisation holder: CIPLA LTD
- Local brand name: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA218483
- Marketing authorisation holder: PRINSTON PHARMA INC
- Local brand name: EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 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 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 7 July 2022; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE in United States?
ZYDUS PHARMS holds the US marketing authorisation.