An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 202810
Company: SUPERNUS PHARMS

Medication Guide

Summary Review

Products on NDA 202810

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202810

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.

Labels for NDA 202810

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

Therapeutic Equivalents for NDA 202810

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	217659	AJANTA PHARMA LTD
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213369	APOTEX
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215796	RICONPHARMA LLC
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	217659	AJANTA PHARMA LTD
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213369	APOTEX
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215796	RICONPHARMA LLC
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	217659	AJANTA PHARMA LTD
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213369	APOTEX
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215796	RICONPHARMA LLC
OXTELLAR XR	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202810	SUPERNUS PHARMS

Top