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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213375

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NDA 213375 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 213375

Tradename:	VIGABATRIN
Applicant:	Alkem Labs Ltd
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 213375

Medical Subject Heading (MeSH) Categories for 213375

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 213375

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	213375	ANDA	Ascend Laboratories, LLC	67877-674	67877-674-63	50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	500MG/PACKET
Approval Date:	Dec 2, 2020	TE:	AA	RLD:	No

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