Documents
Application Sponsors
| NDA 205122 | UPSHER SMITH LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | 1 | QUDEXY XR | TOPIRAMATE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | 1 | QUDEXY XR | TOPIRAMATE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | 1 | QUDEXY XR | TOPIRAMATE |
| 004 | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | 1 | QUDEXY XR | TOPIRAMATE |
| 005 | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | 1 | QUDEXY XR | TOPIRAMATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2014-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2015-06-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2017-03-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-02-18 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2022-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 6 |
TE Codes
| 001 | Prescription | BC |
| 002 | Prescription | BC |
| 003 | Prescription | BC |
| 004 | Prescription | AB2 |
| 005 | Prescription | BC |
CDER Filings
UPSHER SMITH LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 205122
[companyName] => UPSHER SMITH LABS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/205122s010lbl.pdf#page=60"]
[products] => [{"drugName":"QUDEXY XR","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"QUDEXY XR","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"QUDEXY XR","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"QUDEXY XR","activeIngredients":"TOPIRAMATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"QUDEXY XR","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"02\/14\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205122s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205122s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205122s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205122s003s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205122s003s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205122s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205122s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205122s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205122s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205122Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205122Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205122Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/14\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/205122s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205122Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"02\/21\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205122s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205122Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/29\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205122s003s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205122Orig1s003s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/29\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205122s003s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205122Orig1s003s005ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205122Orig1s003TAltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/30\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205122s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205122Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-02-14
)
)