Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213405
Company: TORRENT
Company: TORRENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | LENALIDOMIDE | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 25MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LENALIDOMIDE | LENALIDOMIDE | 20MG | CAPSULE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/2023 | ORIG-2 | Approval | STANDARD |
Label is not available on this site. |
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| 02/17/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2023 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |