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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213390


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NDA 213390 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 213390
Tradename:VIGABATRIN
Applicant:Propel Pharma
Ingredient:vigabatrin
Patents:0
Pharmacology for NDA: 213390
Medical Subject Heading (MeSH) Categories for 213390
Suppliers and Packaging for NDA: 213390
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIGABATRIN vigabatrin FOR SOLUTION;ORAL 213390 ANDA Biocon Pharma Inc. 70377-089 70377-089-01 50 PACKET in 1 CARTON (70377-089-01) / 10 mL in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength500MG/PACKET
Approval Date:Jul 29, 2021TE:RLD:No

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