Last Updated: June 17, 2026

Details for New Drug Application (NDA): 077802

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NDA 077802 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 Ltd, 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-one NDAs. It is available from forty-one 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. Forty-three suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 077802

Tradename:	OXCARBAZEPINE
Applicant:	Glenmark Pharms Ltd
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 077802

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 077802

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	077802	ANDA	Coupler LLC	67046-0179	67046-0179-3	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0179-3)
OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	077802	ANDA	Coupler LLC	67046-0868	67046-0868-3	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0868-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Oct 9, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Oct 9, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Oct 9, 2007	TE:	AB	RLD:	No

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