Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200475
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 12/19/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2021 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/29/2021 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/29/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |