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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215601

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NDA 215601 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 215601

Tradename:	VIGABATRIN
Applicant:	Aurobindo Pharma Ltd
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 215601

Medical Subject Heading (MeSH) Categories for 215601

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 215601

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	215601	ANDA	Aurobindo Pharma Limited	59651-367	59651-367-01	1 BOTTLE in 1 CARTON (59651-367-01) / 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 10, 2022	TE:	AB	RLD:	No

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