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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213104

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NDA 213104 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 213104

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

Pharmacology for NDA: 213104

Medical Subject Heading (MeSH) Categories for 213104

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 213104

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	TABLET;ORAL	213104	ANDA	Hikma Pharmaceuticals USA Inc	0054-0652	0054-0652-25	100 TABLET in 1 BOTTLE (0054-0652-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Aug 29, 2022	TE:	AB	RLD:	No

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