Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211579
Company: LUPIN LTD
Company: LUPIN LTD
| 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 |
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-2 | Tentative Approval | STANDARD |
Label is not available on this site. |
|||
| 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 LTD |
| 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 LTD |
| 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 LTD |
| 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 LTD |
| 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 |