Details for New Drug Application (NDA): 209652

NDA 209652 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, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-eight 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 209652

Tradename:	OXCARBAZEPINE
Applicant:	Bionpharma
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 209652

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 209652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	209652	ANDA	Bionpharma Inc.	69452-125	69452-125-50	1 BOTTLE, GLASS in 1 CARTON (69452-125-50) / 250 mL in 1 BOTTLE, GLASS
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	209652	ANDA	Bionpharma Inc.	69452-125	69452-125-51	1 BOTTLE, PLASTIC in 1 CARTON (69452-125-51) / 250 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Nov 4, 2022	TE:	AB	RLD:	No

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