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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213469

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NDA 213469 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 213469

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

Medical Subject Heading (MeSH) Categories for 213469

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	500MG/PACKET
Approval Date:	Apr 24, 2020	TE:		RLD:	No

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