Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217830
Company: MACLEODS PHARMACEUTICALS LTD
Company: MACLEODS PHARMACEUTICALS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE | ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE | 60MG | TABLET | None (Tentative Approval) | None | No | No |
| ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE | ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE | 5MG | TABLET | None (Tentative Approval) | None | No | No |
| ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE | ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/17/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |