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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 209822

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NDA 209822 describes VIGABATRIN, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Endo Operations, Granules, Invagen Pharms, MSN, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Hikma, Ryan Labs, and Upsher Smith Labs, and is included in twenty-five NDAs. It is available from fifteen suppliers. Additional details are available on the VIGABATRIN profile page.

The generic ingredient in VIGABATRIN is vigabatrin. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

Summary for 209822

Tradename:	VIGABATRIN
Applicant:	Teva Pharms Usa
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 209822

Medical Subject Heading (MeSH) Categories for 209822

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 209822

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	209822	ANDA	Actavis Pharma, Inc.	0591-3851	0591-3851-01	100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 14, 2019	TE:	AB	RLD:	No

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