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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 215707

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NDA 215707 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 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 215707

Tradename:	VIGABATRIN
Applicant:	Zydus Lifesciences
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 215707

Medical Subject Heading (MeSH) Categories for 215707

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 215707

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	215707	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1287	70710-1287-1	100 TABLET, FILM COATED in 1 BOTTLE (70710-1287-1)
VIGABATRIN	vigabatrin	TABLET;ORAL	215707	ANDA	Zydus Lifesciences Limited	70771-1654	70771-1654-1	100 TABLET, FILM COATED in 1 BOTTLE (70771-1654-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 19, 2022	TE:	AB	RLD:	No

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