oxcarbazepine Extended Release Oral Tablet

Brand(s)
Oxtellar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Supernus (2013-01-17)
Oldest Current Product
2013-01-17
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\OXCARBAZEPINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\OXCARBAZEPINE
SPL Active
ORAL\TABLET\OXCARBAZEPINE
SPL Moiety
ORAL\TABLET\OXCARBAZEPINE

product(s) by strength(s)

24 hr oxcarbazepine 150 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1177720121OxtellarNDASupernus2013-01-17OXCARBAZEPINEORALTABLETNDA202810aa610e56-1d1d-11e1-8bc2-0800200c9a66

24 hr oxcarbazepine 300 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1177720122OxtellarNDASupernus2013-01-17OXCARBAZEPINEORALTABLETNDA202810aa610e56-1d1d-11e1-8bc2-0800200c9a66

24 hr oxcarbazepine 600 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1177720123OxtellarNDASupernus2013-01-17OXCARBAZEPINEORALTABLETNDA202810aa610e56-1d1d-11e1-8bc2-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202810OXTELLAR XRSUPERNUS PHARMACEUTICALS INC2012-10-19p7910131, ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
p7722898, SUBSTANCE
p8617600, SUBSTANCE
p8821930, SUBSTANCE
p9119791, ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
NEW DOSAGE FORM [2015-10-19]NDA202810_001, NDA202810_002, NDA202810_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202810_001RXOXCARBAZEPINE (150MG)ORALTABLET, EXTENDED RELEASEFalse2012-10-19OXTELLAR XR
2NDA202810_002RXOXCARBAZEPINE (300MG)ORALTABLET, EXTENDED RELEASEFalse2012-10-19OXTELLAR XR
3NDA202810_003RXOXCARBAZEPINE (600MG)ORALTABLET, EXTENDED RELEASETrue2012-10-19OXTELLAR XR

patent(s)

#idexpiration dateapplication(s)
1p7722898 (view patent)2027-04-13NDA202810
2p7910131 (view patent)2027-04-13NDA202810
3p8617600 (view patent)2027-04-13NDA202810
4p8821930 (view patent)2027-04-13NDA202810
5p9119791 (view patent)2027-04-13NDA202810

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1aa610e56-1d1d-11e1-8bc2-0800200c9a66 (view SPL)These highlights do not include all the information needed to use OXTELLAR XR safely and effectively. See full prescribing information for OXTELLAR XR. OXTELLAR XR (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000prescriptionHuman PrescriptionSupernusMANUFACTURE2013-01-173177720121, 177720122, 177720123

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII