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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 210196

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NDA 210196 describes VIGADRONE, which is a drug marketed by Aucta and is included in one NDA. It is available from one supplier. Additional details are available on the VIGADRONE profile page.

The generic ingredient in VIGADRONE is vigabatrin. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
Summary for 210196
Formulation / Manufacturing:see details
Pharmacology for NDA: 210196
Medical Subject Heading (MeSH) Categories for 210196
Suppliers and Packaging for NDA: 210196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIGADRONE vigabatrin FOR SOLUTION;ORAL 210196 ANDA Upsher-Smith Laboratories, LLC 0245-0556 0245-0556-50 50 PACKET in 1 CARTON (0245-0556-50) > 10 mL in 1 PACKET (0245-0556-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength500MG/PACKET
Approval Date:Jun 21, 2018TE:AARLD:No

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Boehringer Ingelheim

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