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Last Updated: April 15, 2024

Details for New Drug Application (NDA): 090239

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NDA 090239 describes OXCARBAZEPINE, which is a drug marketed by Amneal Pharms, Aucta, Bionpharma, Carnegie, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Medley Pharms, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-four NDAs. It is available from twenty-seven 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. Thirty suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 090239

Tradename:	OXCARBAZEPINE
Applicant:	Jubilant Cadista
Ingredient:	oxcarbazepine
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jan 25, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Jan 25, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jan 25, 2010	TE:		RLD:	No

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