Last Updated: November 2, 2026

Details for New Drug Application (NDA): 219241

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NDA 219241 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Macleods Pharms, MSN, Pai Holdings, Rubicon Research, Steranco Hlthcare, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Epic Pharma Llc, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, Umedica Labs Pvt, and Zydus, and is included in thirty-two NDAs. It is available from forty-four suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There is one drug master file entry for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 219241

Tradename:	OXCARBAZEPINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 219241

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 219241

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	219241	ANDA	Aurobindo Pharma Limited	59651-785	59651-785-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-785-01)
OXCARBAZEPINE	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	219241	ANDA	Aurobindo Pharma Limited	59651-786	59651-786-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-786-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Apr 30, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Apr 30, 2025	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Apr 30, 2025	TE:		RLD:	No

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