Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219755
Company: INVENTIA HEALTHCARE LIMITED
Company: INVENTIA HEALTHCARE LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | 1000MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | 500MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE | 2.5MG | TABLET, EXTENDED RELEASE | 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 |
|---|---|---|---|---|---|---|---|
| 04/09/2026 | ORIG-1 | Tentative Approval | STANDARD |
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