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Generated: November 20, 2018

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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 are two patents 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 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 021285
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:May 25, 2001TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 12, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

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