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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021285

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NDA 021285 describes TRILEPTAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the TRILEPTAL profile page.

The generic ingredient in TRILEPTAL is oxcarbazepine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 021285
Tradename:TRILEPTAL
Applicant:Novartis
Ingredient:oxcarbazepine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021285
Suppliers and Packaging for NDA: 021285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285 NDA Novartis Pharmaceuticals Corporation 0078-0357 0078-0357-52 250 mL in 1 BOTTLE (0078-0357-52)
TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285 NDA AUTHORIZED GENERIC Sandoz Inc 0781-6270 0781-6270-43 250 mL in 1 BOTTLE (0781-6270-43)
Paragraph IV (Patent) Challenges for 021285
Tradename Dosage Ingredient NDA Submissiondate
TRILEPTAL SUSPENSION;ORAL oxcarbazepine 021285 2006-12-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:May 25, 2001TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

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