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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 eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for NDA: 021285

Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 021285

Suppliers and Packaging for NDA: 021285

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;ORAL 021285 NDA Novartis Pharmaceuticals Corporation 0078-0357 0078-0357-52 250 mL in 1 BOTTLE (0078-0357-52)
SUSPENSION;ORAL 021285 NDA AUTHORIZED GENERIC Sandoz Inc 0781-6270 0781-6270-43 250 mL in 1 BOTTLE (0781-6270-43)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:May 25, 2001TE:ABRLD:Yes
Patent:7,037,525*PEDPatent Expiration:Aug 12, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:8,119,148*PEDPatent Expiration:Jun 19, 2021Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.