Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205122
Company: UPSHER SMITH LABS
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 | AB2 | Yes | No |
| QUDEXY XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| QUDEXY XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| QUDEXY XR | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| QUDEXY XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|
| 03/28/2024 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205122s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205122Orig1s016ltr.pdf | |
| 12/02/2022 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205122Orig1s014ltr.pdf | |
| 02/04/2022 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205122Orig1s012ltr.pdf | |
| 02/18/2021 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205122s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205122Orig1s011ltr.pdf | |
| 02/14/2020 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205122s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205122Orig1s010ltr.pdf | |
| 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/2016/205122Orig1s003TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205122Orig1s003s005ltr.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 |
|---|---|---|---|---|---|
| 03/28/2024 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205122s016lbl.pdf | |
| 03/28/2024 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205122s016lbl.pdf | |
| 12/02/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s014lbl.pdf | |
| 02/04/2022 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s012lbl.pdf | |
| 02/04/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s012lbl.pdf | |
| 02/18/2021 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205122s011lbl.pdf | |
| 02/18/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205122s011lbl.pdf | |
| 02/14/2020 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205122s010lbl.pdf | |
| 02/14/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205122s010lbl.pdf | |
| 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
CAPSULE, EXTENDED RELEASE;ORAL; 25MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 150MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |
CAPSULE, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| QUDEXY XR | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 205122 | UPSHER SMITH LABS |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210278 | GLENMARK PHARMS LTD |
| TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 208949 | ZYDUS |