Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212373
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 5MG;1000MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 12.5MG;500MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 12.5MG;1000MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/2025 | ORIG-1 | Tentative Approval | STANDARD |
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