• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal BDD-0779328-0/9/1


Manufacturer FEI3003819155
Manufacturer NameSanofi-Synthelabo Phils. Inc.  
Manufacturer Address line 1108 Herrera Street  
Manufacturer Address line 2  
Manufacturer's CityMakati City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53JD01  
Importer's Product DescriptionLECTACYD PINK  
Refusal Date05-Feb-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0779328-0/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
-
-