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Generated: November 19, 2018

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Details for New Drug Application (NDA): 020427

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NDA 020427 describes SABRIL, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the SABRIL profile page.

The generic ingredient in SABRIL is vigabatrin. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
Summary for 020427
Tradename:SABRIL
Applicant:Lundbeck Pharms Llc
Ingredient:vigabatrin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020427
Medical Subject Heading (MeSH) Categories for 020427
Suppliers and Packaging for NDA: 020427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SABRIL vigabatrin TABLET;ORAL 020427 NDA Lundbeck Pharmaceuticals LLC 67386-111 67386-111-01 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 21, 2009TE:RLD:Yes

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Dow

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