Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202810
Company: SUPERNUS PHARMS
Company: SUPERNUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXTELLAR XR | OXCARBAZEPINE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
OXTELLAR XR | OXCARBAZEPINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
OXTELLAR XR | OXCARBAZEPINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/19/2012 | 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/2012/202810s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202810Org1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810_oxtellarxr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202810Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/14/2024 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202810s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202810Orig1s020ltr.pdf | |
08/08/2023 | SUPPL-14 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202810Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202810Orig1s014ltr.pdf | |
12/13/2018 | SUPPL-10 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202810s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202810s010ltr.pdf | |
06/17/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202810Orig1s005ltr.pdf | |
09/11/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/23/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/14/2013 | 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 |
---|---|---|---|---|---|
08/14/2024 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202810s020lbl.pdf | |
08/08/2023 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202810Orig1s014lbl.pdf | |
12/13/2018 | SUPPL-10 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202810s010lbl.pdf | |
12/04/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202810s005lbl.pdf | |
10/19/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000lbl.pdf |
OXTELLAR XR
TABLET, EXTENDED RELEASE;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213369 | APOTEX |
OXTELLAR XR | OXCARBAZEPINE | 150MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202810 | SUPERNUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213369 | APOTEX |
OXTELLAR XR | OXCARBAZEPINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202810 | SUPERNUS PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213369 | APOTEX |
OXTELLAR XR | OXCARBAZEPINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 202810 | SUPERNUS PHARMS |