Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091338
Company: TORRENT PHARMS LTD
Company: TORRENT PHARMS LTD
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/29/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/091338Orig1s000OtherActionLtrs.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2020 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |