FDA — authorised 9 December 2016
- Application: NDA208658
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: SYNJARDY XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Flozin in United States
FDA authorised Flozin on 9 December 2016
Marketing authorisations
FDA — authorised 27 February 2017
- Application: NDA209091
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: QTERN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2022
- Application: ANDA212138
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: EMPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211506
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211467
- Marketing authorisation holder: MICRO LABS
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211468
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211470
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211478
- Marketing authorisation holder: MSN
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved MSN's Dapagliflozin (Flozin) on 6 April 2026. This approval was granted through the standard expedited pathway. Dapagliflozin is indicated for oral tablet use. The marketing authorisation holder is MSN.
FDA — authorised 6 April 2026
- Application: ANDA211482
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211156
- Marketing authorisation holder: INVENTIA
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA212421
- Marketing authorisation holder: LAURUS GENERICS INC
- Local brand name: EMPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA217049
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA217055
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: EMPAGLIFLOZIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA216119
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211439
- Marketing authorisation holder: HETERO LABS UNIT III
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211442
- Marketing authorisation holder: APOTEX INC
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA219408
- Marketing authorisation holder: SCIEGEN PHARMACEUTICALS INC
- Local brand name: DAPAGLIFLOZIN
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA212382
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: EMPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA212365
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: EMPAGLIFLOZIN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Flozin approved in United States?
Yes. FDA authorised it on 9 December 2016; FDA authorised it on 27 February 2017; FDA authorised it on 3 August 2022.
Who is the marketing authorisation holder for Flozin in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.