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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215109

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NDA 215109 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 215109

Tradename:	VIGABATRIN
Applicant:	Dexcel
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 215109

Medical Subject Heading (MeSH) Categories for 215109

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 215109

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	215109	ANDA	Edenbridge Pharmaceuticals LLC.	42799-950	42799-950-01	100 TABLET in 1 BOTTLE (42799-950-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Sep 23, 2021	TE:	AB	RLD:	No

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