Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210811
Company: CIPLA LIMITED
Company: CIPLA LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE | 50MG | TABLET | None (Tentative Approval) | None | No | No |
| DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE | 300MG | TABLET | None (Tentative Approval) | None | No | No |
| DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |