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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215519

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NDA 215519 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 215519

Tradename:	VIGABATRIN
Applicant:	Ryan Labs
Ingredient:	vigabatrin
Patents:	0

Medical Subject Heading (MeSH) Categories for 215519

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 28, 2023	TE:	AB	RLD:	No

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