Last Updated: June 9, 2026

Details for New Drug Application (NDA): 207300

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NDA 207300 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 207300

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

Pharmacology for NDA: 207300

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 207300

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	207300	ANDA	Macleods Pharmaceuticals Limited	33342-259	33342-259-67	1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Jul 11, 2025	TE:	AB	RLD:	No

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