Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201635
Company: SUPERNUS PHARMS
Company: SUPERNUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TROKENDI XR | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | No |
| TROKENDI XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | No |
| TROKENDI XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | No |
| TROKENDI XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB1 | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/16/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201635Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201635Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201635Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2024 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201635s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201635Orig1s032ltr.pdf | |
| 10/07/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201635Orig1s030ltr.pdf | |
| 02/03/2022 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201635Orig1s029ltr.pdf | |
| 11/18/2020 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201635s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201635orig1s025ltr.pdf | |
| 02/21/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201635s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201635Orig1s020ltr.pdf | |
| 01/03/2018 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201635s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201635Orig1s018ltredt.pdf | |
| 04/05/2017 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201635Orig1s011s017ltr.pdf | |
| 12/22/2016 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201635s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s014ltr.pdf | |
| 08/18/2016 | SUPPL-13 |
Label is not available on this site. |
|||
| 03/16/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2017 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201635Orig1s011TAltr.pdf | |
| 10/12/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201635s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201635Orig1s007ltr.pdf | |
| 04/17/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/04/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201635s032lbl.pdf | |
| 10/07/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s030lbl.pdf | |
| 02/03/2022 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s029lbl.pdf | |
| 11/18/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201635s025lbl.pdf | |
| 02/21/2019 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201635s020lbl.pdf | |
| 02/21/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201635s020lbl.pdf | |
| 01/03/2018 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201635s018lbl.pdf | |
| 01/03/2018 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201635s018lbl.pdf | |
| 04/05/2017 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf | |
| 04/05/2017 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf | |
| 08/18/2016 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201635s014lbl.pdf | |
| 05/08/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201635s007lbl.pdf | |
| 08/16/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201635s000lbl.pdf |
TROKENDI XR
CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 206210 | ACTAVIS LABS FL |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217248 | ALKEM LABS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 217231 | DR REDDYS |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 205976 | PAR PHARM |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 207382 | ZYDUS |
| TROKENDI XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB1 | 201635 | SUPERNUS PHARMS |