Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077324
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/15/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/24/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2010 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 03/15/2010 | SUPPL-2 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 04/15/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |