Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205122
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUDEXY XR TOPIRAMATE 25MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BC Yes No
QUDEXY XR TOPIRAMATE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BC Yes No
QUDEXY XR TOPIRAMATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BC Yes No
QUDEXY XR TOPIRAMATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
QUDEXY XR TOPIRAMATE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription BC 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
03/11/2014 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205122s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205122Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205122Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205122s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205122Orig1s008ltr.pdf
03/29/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205122Orig1s003s005ltr.pdf
03/29/2017 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205122Orig1s003s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205122Orig1s003TAltr.pdf
06/16/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/30/2015 SUPPL-1 Efficacy-New Indication, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205122s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205122Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205122s008lbl.pdf
03/29/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf
03/29/2017 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf
03/30/2015 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205122s001lbl.pdf
03/30/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205122s001lbl.pdf
03/11/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205122s000lbl.pdf

QUDEXY XR

There are no Therapeutic Equivalents.

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