Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079153
Company: TORRENT PHARMS
Company: TORRENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| TOPIRAMATE | TOPIRAMATE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| TOPIRAMATE | TOPIRAMATE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| TOPIRAMATE | TOPIRAMATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/27/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079153s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/24/2019 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2014 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/29/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/11/2010 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2010 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-3 | REMS-Proposal, Labeling |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-2 | Labeling |
Label is not available on this site. |