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Generated: November 13, 2018

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Details for New Drug Application (NDA): 202810

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NDA 202810 describes OXTELLAR XR, which is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OXTELLAR XR profile page.

The generic ingredient in OXTELLAR XR is oxcarbazepine. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 202810
Tradename:OXTELLAR XR
Applicant:Supernus Pharms
Ingredient:oxcarbazepine
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 202810
Suppliers and Packaging for NDA: 202810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810 NDA Supernus 17772-121 17772-121-01 100 TABLET in 1 BOTTLE (17772-121-01)
OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810 NDA Supernus 17772-121 17772-121-10 5 TABLET in 1 BLISTER PACK (17772-121-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Oct 19, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 13, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 13, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
Patent:➤ Try a Free TrialPatent Expiration:Apr 13, 2027Product Flag?YSubstance Flag?Delist Request?

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