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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 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AEK-7031460-0/1/2 26-May-2005 63ACA99 3005035932 Jagan Mohan Rao India
 
112-6432939-2/5/1 23-May-2005 63ACY02 1000168130 Merck Sharp & Dohme Limited United Kingdom
 
112-6251795-6/1/2 04-May-2005 63BAY25 3003615524 Glaxo Smith Kline India
 
112-6299703-4/1/1 04-May-2005 63BBY32 3003589503 AstraZeneca UK Ltd United Kingdom
 
110-1037261-7/1/1 31-May-2005 63BDQ25 3003878140 GlaxoSmithKline Inc. Canada
 
609-0297026-2/1/1 25-May-2005 63ECS13 3002806754 Cosma S.P.A. Italy
 
112-6900127-7/1/1 19-May-2005 63EDB99 3004464238 Dr. Reddy's Laboratories Limited India
 
002-6121964-6/6/1 13-May-2005 63HAL08 3004518571 Ashraf Abd El Maksoud Ahmed Egypt
 
D40-0244900-5/1/1 25-May-2005 63HCL10 1000225411 Inalco S.P.A. Italy
 
110-0991948-5/1/1/A 27-May-2005 63NCK04 1000460924 Ups/Kaf Korea, Republic Of (South)
 
NS6-0017098-0/6/1/A 23-May-2005 63R04 1000300384 Colgate Palmolive SA de CV Mexico
 
NS6-0017098-0/6/1/B 23-May-2005 63R04 1000300384 Colgate Palmolive SA de CV Mexico
 
NS6-0017098-0/6/1/C 23-May-2005 63R04 1000300384 Colgate Palmolive SA de CV Mexico
 
DP4-0320312-9/2/1 03-May-2005 63RAJ04 3002476346 Procter Canada
 
144-7028801-2/1/1/D 24-May-2005 63RAY05 3004415710 Church & Dwight Ltd Canada
 
144-7028801-2/1/1/G 24-May-2005 63RAY05 3004415710 Church & Dwight Ltd Canada
 
110-0957447-0/1/1 18-May-2005 63RBJ04 3000245254 Colgate-Palmolive Co Canada
 
AP5-0002921-4/1/6 19-May-2005 63RBJ99 3005073720 Telaga Artha Prima Indonesia
 
110-0729187-9/1/1 12-May-2005 63RBL99 3005060960 Thermafat Sa De Cvb Mexico
 
112-6123878-6/1/2 12-May-2005 63RCJ04 3000166001 Germiphene Corporation Canada
 
112-6123878-6/1/4 12-May-2005 63RCJ04 3000166001 Germiphene Corporation Canada
 
M76-6014177-2/7/1 12-May-2005 63RCJ04 3000166001 Germiphene Corporation Canada
 
112-6123878-6/1/1 12-May-2005 63RCQ04 3000166001 Germiphene Corporation Canada
 
112-6123878-6/1/3 12-May-2005 63RCQ04 3000166001 Germiphene Corporation Canada
 
M76-6014177-2/8/1 12-May-2005 63TCJ99 1824299 E.C. Moore Co. United States
 
112-6271116-1/1/1 04-May-2005 63WIZ07 3004368221 Prachi Pharmaceuti India
 
AEK-6497106-8/1/1 26-May-2005 63XAZ99 3003747021 Hauret Sandrine Saint Christopher & Nevis
 
AEK-6497106-8/1/2 26-May-2005 63XAZ99 3003747021 Hauret Sandrine Saint Christopher & Nevis
 
AEK-6523852-5/1/3 26-May-2005 63XCY99 3004495602 St Kitts Marriott Resort Saint Christopher & Nevis
 
AEK-6488253-9/1/1 26-May-2005 63XCY99 3004910448 Liow Sai Cheong Malaysia
 
112-6917030-4/1/1 26-May-2005 63XDH99 3005114469 Janssen Cilag Lab United States
 
112-6864238-6/2/1 18-May-2005 63XDY99 3005108649 Laboratorios Ifa Srl Bolivia
 
112-6864238-6/2/2 18-May-2005 63XDY99 3005108650 Laboratorios Inti Bolivia
 
112-6864238-6/2/3 18-May-2005 63XDY99 3005108648 Bago Bolivia
 
112-6864238-6/2/4 18-May-2005 63XDY99 3005108648 Bago Bolivia
 
M51-0015015-5/1/1/B 09-May-2005 63XIY99 3003816924 Conta Care Ophthalmics Pvt Ltd. India
 
AEK-6535994-1/1/1 12-May-2005 63XRY99 3005062868 Juana Portorreal Dominican Republic
 
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