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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AEK-7633883-5/1/3 27-Mar-2006 64BDA25 3005545147 Mark Riffel Canada
 
112-0222491-3/1/2 21-Mar-2006 64BDB07 3003679117 Approved Prescription Services,Ltd. United Kingdom
 
112-0570975-3/1/1 06-Mar-2006 64DBK99 3005320466 Opto-Pharm Pte Ltd. Singapore
 
112-0555600-6/1/1 06-Mar-2006 64DBL99 3005320466 Opto-Pharm Pte Ltd. Singapore
 
AEK-7094871-2/1/1 31-Mar-2006 64EIE99 3001085261 Clinical Trail Services United Kingdom
 
AEK-7096826-4/1/1 28-Mar-2006 64FCA24 3005610256 Aysen Topay Turkey
 
112-0773865-1/1/1 22-Mar-2006 64GCP99 3004678145 Organon Nederland Bv Netherlands
 
XXX-0141695-8/1/5 28-Mar-2006 64GDA19 1000206786 Wyeth & Ayerst Canada
 
112-0746969-5/1/1 21-Mar-2006 64HBY02 3004651273 CV Technologies Inc. Canada
 
112-0451326-3/4/1 23-Mar-2006 64HDB99 3002807274 Zambon Switzerland Ltd. Switzerland
 
AEK-7093904-2/1/1 29-Mar-2006 64JCB99 3005585107 Andrzej T. Modzelewski Poland
 
231-4140753-9/1/1 03-Mar-2006 64JDV01 3005451499 Shin Yang Oxygen Industry Co., Ltd. Korea, Republic Of (South)
 
112-0744174-4/1/1/D 22-Mar-2006 64LCJ06 3003705104 Shalina Laboratories Limited India
 
112-0744174-4/1/1/E 22-Mar-2006 64LCJ06 3004144638 BELTAPHARM S.p.A. Italy
 
112-0744174-4/1/1/G 22-Mar-2006 64LCJ08 1000404811 Regal Pharmaceuticals Limited Kenya
 
112-0744174-4/1/1/C 22-Mar-2006 64LCJ67 1000147278 C & C International Ltd. United Kingdom
 
112-0744174-4/1/1/F 22-Mar-2006 64LCJ67 3004144638 BELTAPHARM S.p.A. Italy
 
112-0744174-4/1/1/H 22-Mar-2006 64LCJ67 3004144640 VINCO PHARMACEUTICAL Italy
 
336-2591794-6/1/1 09-Mar-2006 64LCS37 3002808153 Shandong Xinhua Pharmaceutical Co., Ltd. China
 
112-0451326-3/3/1 23-Mar-2006 64LDB50 3004492403 Beacon Pharmaceuticals Ltd United Kingdom
 
XXX-0142505-8/1/1 30-Mar-2006 64LDJ67 3005609479 Laboratorios Wellco Guatemala
 
112-0222491-3/1/1 21-Mar-2006 64LDK02 3006736885 Glaxosmithkline United Kingdom
 
XXX-0142505-8/1/3 30-Mar-2006 64LDZ61 3003683750 Lisapharma Lab It. Biochim. Pharmaceutico Italy
 
ALN-4487679-3/1/1 28-Mar-2006 64PCS09 3002806691 Cipla, Ltd. India
 
112-0469045-9/1/1/B 04-Mar-2006 64UCA06 3005582261 Laboratories Pharmaderm Colombia
 
XXX-0141584-4/1/1 31-Mar-2006 64UCH08 3005593440 Francoise Pellerin France
 
XXX-0141976-2/1/1 28-Mar-2006 64XCE11 1000249433 R.P. Scherer Gmbh Germany
 
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