➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
Dow
Baxter

Last Updated: August 15, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077794

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 077794 describes OXCARBAZEPINE, which is a drug marketed by Amneal Pharms, Hikma, Sun Pharm Inds Ltd, Ani Pharms Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Rubicon, Sun Pharm Inds, and Taro, and is included in eleven NDAs. It is available from fifteen suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 077794
Tradename:OXCARBAZEPINE
Applicant:Sun Pharm Inds
Ingredient:oxcarbazepine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077794
Suppliers and Packaging for NDA: 077794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8153 0615-8153-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8153-39)
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8292 0615-8292-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8292-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Johnson and Johnson
Mallinckrodt
Colorcon
McKesson

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.