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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077802

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NDA 077802 describes OXCARBAZEPINE, which is a drug marketed by Amneal Pharms, Sun Pharm Inds Ltd, West-ward Pharms Int, Ani Pharms Inc, Apotex Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, and Taro, and is included in eleven NDAs. It is available from twenty-three suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are nineteen drug master file entries for this compound. Twenty-seven 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
Therapeutic Class:	Anticonvulsants
Formulation / Manufacturing:	see details

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	Rebel Distributors Corp	21695-862	E	21695-862-30
OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	077802	ANDA	Rebel Distributors Corp	21695-862	E	21695-862-60

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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