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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 211420

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NDA 211420 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, 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-five NDAs. It is available from thirty-two 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-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 211420

Tradename:	OXCARBAZEPINE
Applicant:	Renew Pharms
Ingredient:	oxcarbazepine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Jul 9, 2021	TE:		RLD:	No

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