Last Updated: May 3, 2026

Details for New Drug Application (NDA): 217782

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NDA 217782 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, and Zydus, and is included in thirty NDAs. It is available from thirty-nine 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-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 217782

Tradename:	OXCARBAZEPINE
Applicant:	Kanchan Hlthcare
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 217782

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 217782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	217782	ANDA	Marlex Pharmaceuticals, Inc	10135-798	10135-798-41	250 mL in 1 BOTTLE, GLASS (10135-798-41)
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	217782	ANDA	Bryant Ranch Prepack	72162-2631	72162-2631-2	250 mL in 1 BOTTLE, GLASS (72162-2631-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Feb 14, 2024	TE:	AB	RLD:	No

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