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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 217684


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NDA 217684 describes VIGAFYDE, which is a drug marketed by Pyros Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VIGAFYDE profile page.

The generic ingredient in VIGAFYDE 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 217684
Tradename:VIGAFYDE
Applicant:Pyros Pharms
Ingredient:vigabatrin
Patents:1
Pharmacology for NDA: 217684
Medical Subject Heading (MeSH) Categories for 217684
Suppliers and Packaging for NDA: 217684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIGAFYDE vigabatrin SOLUTION;ORAL 217684 NDA Pyros Pharmaceuticals, Inc. 80789-003 80789-003-15 1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Jun 17, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 16, 2039Product Flag?YSubstance Flag?Delist Request?

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