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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 213390

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NDA 213390 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 213390

Tradename:	VIGABATRIN
Applicant:	Propel Pharma
Ingredient:	vigabatrin
Patents:	0

Medical Subject Heading (MeSH) Categories for 213390

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	500MG/PACKET
Approval Date:	Jul 29, 2021	TE:		RLD:	No

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