Details for New Drug Application (NDA): 202961

NDA 202961 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, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-five NDAs. It is available from thirty-two 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. Thirty-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 202961

Tradename:	OXCARBAZEPINE
Applicant:	Amneal Pharms
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 202961

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 202961

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	AvPAK	50268-649	50268-649-30	30 CUP, UNIT-DOSE in 1 TRAY (50268-649-30) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-05)
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	Amneal Pharmaceuticals LLC	65162-649	65162-649-48	10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Sep 17, 2012	TE:	AB	RLD:	No

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