Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201635
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 AB Yes No
TROKENDI XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
TROKENDI XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
TROKENDI XR TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201635s018lbl.pdf
01/03/2018 SUPPL-18 Labeling-Medication Guide 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 = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

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 AB 207382 ZYDUS PHARMS
TROKENDI XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 201635 SUPERNUS PHARMS

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