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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 210042

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NDA 210042 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, Granules, Invagen Pharms, MSN, Ph Health, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Carnegie, Hikma, and Upsher Smith Labs, and is included in twenty-five NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

Summary for 210042

Tradename:	VIGABATRIN
Applicant:	Amneal Pharms
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 210042

Medical Subject Heading (MeSH) Categories for 210042

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 210042

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	210042	ANDA	Amneal Pharmaceuticals NY LLC	60219-1424	60219-1424-1	100 TABLET in 1 BOTTLE (60219-1424-1)
VIGABATRIN	vigabatrin	TABLET;ORAL	210042	ANDA	Amneal Pharmaceuticals NY LLC	69238-1424	69238-1424-1	100 TABLET in 1 BOTTLE (69238-1424-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 22, 2022	TE:		RLD:	No

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