Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076314
Company: MYLAN
Company: MYLAN
| 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)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2024 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/04/2024 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2024 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2011 | SUPPL-9 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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| 10/30/2010 | SUPPL-3 | Labeling-Package Insert, REMS-Proposal, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/13/2010 | SUPPL-1 | Labeling, REMS-Proposal |
Label is not available on this site. |