Details for New Drug Application (NDA): 021285

✉ Email this page to a colleague

NDA 021285 describes TRILEPTAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. 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. Thirty-six 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:	0

Pharmacology for NDA: 021285

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	May 25, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021285

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.