Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078582
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 100MG/ML | SOLUTION;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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078582s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/21/2026 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2026 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2026 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2011 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
||
| 09/21/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2009 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |