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Abbreviated New Drug Application (ANDA): 211489
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 2.5MG TABLET None (Tentative Approval) None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/2026 ORIG-1 Approval STANDARD

Label is not available on this site.

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 5MG;1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211595 CIPLA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 10MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 10MG;1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 5MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 5MG;1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211595 CIPLA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 10MG;500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB

TABLET, EXTENDED RELEASE;ORAL; 10MG;1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211563 ALKEM LABS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211489 AUROBINDO PHARMA
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211536 CIPLA LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211579 LUPIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211559 MACLEODS PHARMS LTD
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211466 MICRO LABS
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211479 MSN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211491 SUN PHARM
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211583 TEVA PHARMS USA INC
XIGDUO XR DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 205649 ASTRAZENECA AB
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