Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216063
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLVAPTAN | TOLVAPTAN | 15MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| TOLVAPTAN | TOLVAPTAN | 30MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| TOLVAPTAN | TOLVAPTAN | 45MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| TOLVAPTAN | TOLVAPTAN | 60MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| TOLVAPTAN | TOLVAPTAN | 90MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/04/2023 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216063Orig1s000TAltr.pdf |