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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-0028235-3/1/1 26-Apr-2012 65ADA04 3007743667 Sun Pharma Sikkim India
 
508-0328510-0/1/1 23-Apr-2012 65FBK99 3006476274 Church & Dwight,S. De R.L. De C.V. Mexico
 
112-4607831-0/1/1 20-Apr-2012 65HIY02 3002807874 Pharmacosmos A/S Denmark
 
112-6699135-0/1/1 05-Apr-2012 65JAC31 3004950389 Sun Pharma India
 
112-6932625-7/1/1 27-Apr-2012 65KCA09 3009473054 Pfizer Ecuador
 
112-8661107-8/1/1 06-Apr-2012 65KDK10 3008499684 Health Care Tele Bio Medical Pvt India
 
ED5-0044468-9/6/2/E 19-Apr-2012 65LBJ11 3007094293 Stalder Laboratiories Philippines
 
ED5-0044468-9/6/2/F 19-Apr-2012 65LBJ15 3007094293 Stalder Laboratiories Philippines
 
916-2312623-1/1/1 05-Apr-2012 65LBS11 1000198547 Croda Chemicals Ltd. United Kingdom
 
178-1073184-8/1/1 25-Apr-2012 65PBE02 3009292230 Ocvita Llc, United States
 
XXX-0177590-8/1/1 09-Apr-2012 65Q02 3001137323 UNKNOWN Korea, Republic Of (South)
 
XXX-0177592-0/1/5 09-Apr-2012 65Q31 3004993131 mankind pharma pvt ltd India
 
XXX-0177611-8/1/4 09-Apr-2012 65Q60 3006435067 Ranbaxy Laboratories Limited India
 
AEK-0109187-1/1/1 05-Apr-2012 65QDA22 3006181452 Universal Drug Ser Canada
 
9DE-0900006-6/1/1 28-Apr-2012 65RDQ99 3009405838 Excyton-Excymer Gmbh Switzerland
 
112-9307050-8/1/2 26-Apr-2012 65VAA15 3004909700 Medix S.A Mexico
 
AEK-0275274-5/1/1 02-Apr-2012 65VCC15 3002787660 Roche Pharman Basel Switzerland
 
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