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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 214671

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NDA 214671 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 214671

Tradename:	VIGABATRIN
Applicant:	Zydus Lifesciences
Ingredient:	vigabatrin
Patents:	0

Pharmacology for NDA: 214671

Medical Subject Heading (MeSH) Categories for 214671

Anticonvulsants
Enzyme Inhibitors
GABA Agents

Suppliers and Packaging for NDA: 214671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214671	ANDA	Zydus Pharmaceuticals (USA) Inc.	70710-1494	70710-1494-8	50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1)
VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214671	ANDA	Zydus Lifesciences Limited	70771-1742	70771-1742-8	50 PACKET in 1 CARTON (70771-1742-8) / 10 mL in 1 PACKET (70771-1742-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	500MG/PACKET
Approval Date:	Mar 2, 2023	TE:		RLD:	No

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