FDA — authorised 6 April 2026
- Application: ANDA211563
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE in United States
FDA authorised DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 6 April 2026
Marketing authorisations
FDA — authorised 6 April 2026
- Application: ANDA211579
- Marketing authorisation holder: LUPIN
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211583
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211466
- Marketing authorisation holder: MICRO LABS
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA granted marketing authorisation to MICRO LABS for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, an extended-release oral tablet. This approval is for the treatment of type 2 diabetes. The application number is ANDA211466, and the approval date is 6 April 2026.
FDA — authorised 6 April 2026
- Application: ANDA211479
- Marketing authorisation holder: MSN
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, an extended-release oral tablet, for the treatment of type 2 diabetes. The approval was granted to MSN on 6 April 2026, following a standard expedited pathway. This approval allows MSN to market the product in the United States.
FDA — authorised 6 April 2026
- Application: ANDA211489
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, an extended-release oral tablet, for the treatment of type 2 diabetes. This approval was granted to Aurobindo Pharma on 6 April 2026, following a standard review pathway. The product is indicated for the management of blood sugar levels in adults with type 2 diabetes.
FDA — authorised 6 April 2026
- Application: ANDA211491
- Marketing authorisation holder: SUN PHARM
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved SUN PHARM's DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE for the treatment of type 2 diabetes. This approval was granted on 2026-04-06, following a standard review pathway. The product is an extended-release tablet, administered orally.
FDA — authorised 6 April 2026
- Application: ANDA211595
- Marketing authorisation holder: CIPLA
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211536
- Marketing authorisation holder: CIPLA LTD
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2026
- Application: ANDA211559
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA219755
- Marketing authorisation holder: INVENTIA HEALTHCARE LIMITED
- Local brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 6 April 2026; FDA authorised it on 6 April 2026; FDA authorised it on 6 April 2026.
Who is the marketing authorisation holder for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE in United States?
ALKEM LABS LTD holds the US marketing authorisation.