Orange Book product · Generic (ANDA)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
At a glance
Apr 06, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength
2.5MG;1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 211583
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- 2017XIGDUO XRBrand (NDA)
NDA 205649 · ASTRAZENECA AB
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ANDA 211563 · ALKEM LABS LTD
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211489 · AUROBINDO PHARMA
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211595 · CIPLA
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211536 · CIPLA LTD
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211579 · LUPIN
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211559 · MACLEODS PHARMS LTD
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211466 · MICRO LABS
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211479 · MSN
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211491 · SUN PHARM
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
