Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078042
Company: STRIDES PHARMA
Company: STRIDES 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 |
|---|---|---|---|---|---|
| 02/28/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2011 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
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| 11/22/2010 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/23/2010 | SUPPL-6 | Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |
||
| 04/22/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/26/2010 | SUPPL-2 | Labeling-Patient Package Insert |
Label is not available on this site. |