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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210155


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NDA 210155 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 210155
Tradename:VIGABATRIN
Applicant:Amneal Pharms
Ingredient:vigabatrin
Patents:0
Pharmacology for NDA: 210155
Medical Subject Heading (MeSH) Categories for 210155
Suppliers and Packaging for NDA: 210155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIGABATRIN vigabatrin FOR SOLUTION;ORAL 210155 ANDA Amneal Pharmaceuticals NY LLC 60219-1425 60219-1425-5 50 FOR SOLUTION in 1 CARTON (60219-1425-5)
VIGABATRIN vigabatrin FOR SOLUTION;ORAL 210155 ANDA Amneal Pharmaceuticals NY LLC 69238-1425 69238-1425-5 50 FOR SOLUTION in 1 CARTON (69238-1425-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength500MG/PACKET
Approval Date:Mar 13, 2018TE:AARLD:No

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