3Q2008NEWTEXT DMF # Type SUBMIT DATE HOLDER SUBJECT 20170 II 7/31/2008 CIPLA LTD "MOXIFLOXACIN HYDROCHLORIDE PH. EUR. AS MANUFACTURED IN MAHARASHTRA, INDIA" 20570 II 5/28/2007 MEGAFINE PHARMA (P) LTD MIRTAZAPINE ANHYDROUS USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN NASHIK INDIA 21045 II 3/26/2008 TOPCHEM PHARMACEUTICALS LTD "MALATHION AS MANUFACTURED IN COUNTY SLIGO, IRELAND" 21376 II 8/1/2008 JUBILANT ORGANOSYS LTD "ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN KARNATAKA, INDIA" 21546 II 8/19/2008 CIPLA LTD "TESTOSTERONE USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21580 II 7/23/2008 BAYER HEALTHCARE AG "RIVAROXABAN COATED TABLETS, 10 MG AS MANUFACTURED IN LEVERKUSEN, GERMANY " 21581 II 7/23/2008 BAYER HEALTHCARE AG "RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE AS MANUFACTURED IN WUPPERTAL AND LEVERKUSEN, GERMANY " 21602 II 5/8/2008 NANTONG JINGHUA PHARMACEUTICAL CO LTD "PRIMIDONE AS MANUFACTURED IN JIANGSU, P.R. CHINA" 21614 II 5/9/2008 SHENZHEN HAPPY PHARMACEUTICALS LTD "PHENYLEPHRINE HYDROCHLORIDE AS MANUFACTURED BY HAPPY PHARMACEUTICALS LTD IN SHANDONG PROVINCE, CHINA FOR SHENZHEN HAPPY PHARMACEUTICALS LTD." 21636 II 7/22/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "LANSOPRAZOLE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21643 II 5/14/2008 SANQUIN BLOOD SUPPLY FDN "HOLOTRANSFERRIN AS MANUFACTURED BY SANQUIN PLASMA PRODUCTS IN AMSTERDAM, THE NETHERLANDS AND CAF-DCF CVBA-SCRL IN BRUSSELS, BELGIUM FOR SANQUIN BLOOD SUPPLY FOUNDATION " 21676 II 7/25/2008 IPCA LABORATORIES LTD "ALLOPURINOL AS MANUFACTURED IN MADHYA PRADESH, INDIA" 21677 II 9/20/2008 IPCA LABORATORIES LTD "FENOFIBRATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA" 21680 II 8/12/2008 IPCA LABORATORIES LTD "WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN MADHYA PRADESH, INDIA" 21689 II 7/23/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "SODIUM BICARBONATE (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21692 II 6/7/2008 ERREGIERRE SPA "CHENODEOXYCHOLIC ACID AS MANUFACTURED IN BERGAMO, ITALY " 21698 II 7/25/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "CILASTATIN SODIUM (STERILE) AS MANUFACTURED IN MAHARASHATRA, INDIA" 21699 II 7/31/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "SODIUM CARBONATE (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21705 II 7/23/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "IMIPENEM (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21707 II 7/25/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "IMIPENEM + CILASTATIN SODIUM (STERILE BULK) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21709 II 7/31/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "MEROPENEM + SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21710 II 7/31/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "MEROPENEM (STERILE) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21764 II 9/30/2008 CIPLA LTD "LAMIVUDINE (PROCESS 2) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21781 II 7/8/2008 DR REDDYS LABORATORIES LTD "RIVASTIGMINE HYDROGEN TARTRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21806 II 7/28/2008 PHF SA "THALIDOMIDE AS MANUFACTURED IN OLAINE, LATVIA" 21823 III 7/9/2008 SENXING PHARMACEUTICAL CONSUMABLE (BEIJING) LTD "RUBBER STOPPER AS MANUFACTURED IN BEIJING, P.R. CHINA" 21824 II 7/28/2008 SHASUN CHEMICALS DRUGS LTD "VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE, INDIA" 21825 III 7/25/2008 POLIMERI EUROPA SPA FLEXIRENE MS 20 AS MANUFACTURED IN DUNKERQUE (FRANCE) 21826 II 7/28/2008 MENADIONA SL "QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN" 21827 II 7/28/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD "DULOXETINE HCL AS MANUFACTURED IN BEER SHEVA, ISRAEL" 21828 II 7/10/2008 LAKE CHEMICALS PRIVATE LTD "ALPRAZOLAM AS MANUFACTURED IN BANGALORE, KARNATAKA, INDIA" 21829 III 7/22/2008 HYDRO ALUMINIUM DEUTSCHLAND GMBH "HARP 506/1 AND 506/2 DRUG PACKAGING MATERIALS AS MANUFACTURED IN GREVENBROICH, GERMANY " 21830 II 7/28/2008 ICROM SPA "EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CONCOREZZO (MILAN), ITALY" 21831 III 7/28/2008 KB SEIREN LTD "H20N AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN" 21832 III 7/28/2008 KB SEIREN LTD "H20N-TU22 AS MANUFACTURED IN SHIGA PREFECTURE, JAPAN" 21833 II 7/30/2008 APOTEX PHARMACHEM INC "DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TOLUCA, MEXICO" 21834 II 7/29/2008 ISOCHEM "NEFOPAM HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE" 21835 II 7/24/2008 BAXTER PHARMACEUTICAL SOLUTIONS LLC "0.9% SODIUM CHLORIDE DILUENT, USP AS MANUFACTURED IN BLOOMINGTON, IN" 21836 II 7/29/2008 MEDICHEM MANUFACTURING (MALTA) LTD "MED-200448/M AS MANUFACTURED IN HAL FAR, MALTA" 21837 II 7/28/2008 ESTEVE QUIMICA SA "LEVETIRACETAM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN BANYERES DEL PENEDES (TARRAGONA), SPAIN" 21838 II 7/30/2008 RANBAXY LABORATORIES LTD "DULOXETINE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA" 21839 II 5/30/2008 SYNTHESIA AS "ERGOCALCIFEROL AS MANUFACTURED IN SEMTIN, CZECH REPUBLIC" 21840 III 6/27/2008 AMPACET CORP "AMPACET 19258-A- BLACK COP MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN" 21841 II 7/31/2008 CRYSTAL PHARMA SAU "HYDROCORTISONE BUTYRATE, MICRONIZED AS MANUFACTURED IN BOECILLO (VALLADOLID), SPAIN" 21842 II 7/9/2008 ZHEJIANG ANGLIKANG PHARMACEUTICAL CO LTD "CEFALEXIN MONOHYDRATE (NON-STERILE, BULK FORM) AS MANUFACTURED IN SHENGZHOU, ZHEJIANG, PEOPLE'S REPUBLIC OF CHINA " 21843 IV 7/23/2008 COGNIS GMBH "MONOMULS 90-L 12 AS MANUFACTURED IN DUESSELDORF, GERMANY" 21845 II 7/30/2008 AUROBINDO PHARMA LTD "VALSARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21846 IV 8/1/2008 SYMRISE GBMH CO KG "FRUIT PUNCH FLAVOUR SD 204264 AS MANUFACTURED IN HOLZMINDEN, GERMANY" 21847 IV 8/1/2008 SYMRISE GBMH CO KG "NATURAL PEPPERMINT FLAVOR 290017 AS MANUFACTURED IN HOLZMINDEN, GERMANY" 21848 II 7/30/2008 TAIYO NIPPON SANSO CORP "WATER-18O AS MANUFACTURED IN CHIBA, JAPAN" 21849 III 7/31/2008 SABIC PETROCHEMICALS BV "SABIC LDPE PCG80 AS MANUFACTURED IN GELEEN, THE NETHERLANDS" 21850 II 8/1/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD "ATORVASTATIN CALCIUM AS MANUFACTURED IN PETAH TIQVA, ISRAEL" 21851 II 8/1/2008 ALCHYMARS SPA "EPINASTINE HYDROCHLORIDE AS MANUFACTURED IN CERIANO LAGHETTO (MI), ITALY" 21852 II 7/31/2008 ROLABO OUTSOURCING SL "DOLASETRON MESYLATE AS MANUFACTURED IN ZARAGOZA, SPAIN" 21853 II 8/4/2008 GLENMARK GENERICS LTD "ESZOPICLONE AS MANUFACTURED IN GUJARAT STATE, INDIA" 21854 IV 7/30/2008 NECTAR LIFESCIENCES LTD "MENTHOL USP AS MANUFACTURED IN MOHALI (PUNJAB), INDIA" 21855 III 7/24/2008 SHANDONG PHARMACEUTICAL GLASS CO LTD "BOROSILICATE GLASS (USP TYPE I) BARRELS FOR INJECTABLES FOR PREFILLED SYRINGES AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA" 21856 III 7/24/2008 SHANDONG PHARMACEUTICAL GLASS CO LTD "BOROSILICATE GLASS (USP TYPE I) CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA" 21857 II 8/1/2008 MEDICHEM MANUFACTURING (MALTA) LTD "MED-201570/M AS MANUFACTURED IN HAL FAR, MALTA" 21858 II 7/29/2008 BIOCON LTD "ATORVASTATIN CALCIUM AMORPHOUS AS MANUFACTURED IN BANGALORE, INDIA" 21859 II 8/5/2008 MYLAN DEVELOPMENT CENTRE PRIVATE LTD "SALMETEROL XINAFOATE AS MANUFACTURED IN MAHARASHTRA, INDIA " 21860 II 7/24/2008 CENTAUR CHEMICALS PRIVATE LTD "DIAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21861 II 7/25/2008 SAVIOR LIFETEC CORP "MEROPENEM AND SODIUM CARBONATE (STERILE BULK) AS MANUFACTURED IN TAIWAN, R.O.C." 21862 II 8/6/2008 SEQUENT SCIENTIFIC LTD "METHOXSALEN USP AS MANUFACTURED IN KARNATAKA, INDIA " 21863 II 8/4/2008 EXCELLA GMBH "BICALUTAMIDE MILLED Z AS MANUFACTURED IN FEUCHT, GERMANY" 21864 II 8/5/2008 IWAKI SEIYAKU CO LTD "CETIRIZINE HYDROCHLORIDE AS MANUFACTURED IN SHIZUOKA, JAPAN" 21865 II 9/26/2008 WATSON PHARMA PRIVATE LTD "METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21866 II 8/7/2008 AARTI INDUSTRIES LTD "RANOLAZINE AS MANUFACTURED IN MAHARASHTRA, INDIA " 21867 III 7/23/2008 AMPACET CORP "AMPACET 172954 LIME GREEN POLYPROPYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN" 21868 II 7/5/2008 ISOCHEM "BUFLOMEDIL HYDROCHLORIDE AS MANUFACTURED IN PARIS, FRANCE" 21869 II 8/8/2008 NOVARTIS PHARMACEUTICALS CORP "SMT487 ACETATE (EDOTREOTIDE) AS MANUFACTURED IN BASEL, SWITZERLAND" 21870 II 7/25/2008 KAKEN PHARMACEUTICAL CO LTD "KP-103/B AS MANUFACTURED IN YAMAGATA, JAPAN " 21871 IV 7/28/2008 DOW CORNING CORP "SILASTIC 7-6840 BIOMEDICAL GRADE LIQUID SILICONE RUBBER AS MANUFACTURED IN HEMLOCK, MI" 21872 III 7/30/2008 VEDAT TAMPAS HERMETICAS LTDA "BOTTLES MANUFACTURED IN EMBU SP, BRAZIL" 21873 IV 8/11/2008 FONA INTERNATIONAL INC "827.014 NAT CINNAMON FLAVOR (WONF) AS MANUFACTURED IN GENEVA, IL" 21874 III 7/21/2008 YONWOO CORP "AS30-J/PP AND AS50-J/PP AS MANUFACTURED IN INCHEON, KOREA" 21875 III 7/21/2008 YONWOO CORP "AS30/50-J/PP JAR AS MANUFACTURED IN INCHEON, KOREA" 21877 II 8/12/2008 ELAN DRUG DELIVERY INC "NAPRELAN® (NAPROXEN SODIUM) CONTROLLED-RELEASE TABLETS, 375MG, 500MG, 750MG AS MANUFACTURED IN WESTMEATH, IRELAND" 21878 II 8/14/2008 BASIC PHARMA LIFE SCIENCE PVT. LTD. "CHLORHEXIDINE GLUCONATE AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA" 21879 II 8/12/2008 CORAL DRUGS PVT LTD "FLUTICASONE PROPIONATE AS MANUFACTURED IN HARYANA, INDIA" 21880 II 8/14/2008 FORMOSA LABORATORIES INC "PARICALCITOL AS MANUFACTURED IN TAOYUAN, TAIWAN" 21881 III 8/1/2008 POLYCINE GMBH "APP107 TUBE AS MANUFACTURED IN SCHIFFWEILER, GERMANY" 21882 IV 8/15/2008 NATIONAL ADHESIVES "DURO-TAK® 87-613A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC " 21883 II 8/13/2008 APICORE LLC "ISOSULFAN BLUE AS MANUFACTURED IN SOMERSET, NJ" 21884 II 7/30/2008 POLYDRUG LABORATORIES PVT LTD "METOPROLOL SUCCINATE AS MANUFACTURED IN MAHARASHTRA, INDIA" 21885 III 7/7/2008 BASF SE "LURAN® HD-20 AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL REPUBLIC OF GERMANY " 21886 II 8/14/2008 PHARMAZELL (INDIA) PRIVATE LTD "L-CYSTINE AS MANUFACTURED IN CHENNAI, INDIA" 21887 II 8/5/2008 FIS FABBRICA ITALIANA SINTETICI SPA NITROFURANTOIN MONOHYDRATE (CODE 1042) AS MANUFACTURED IN VICENZA (ITALY) 21888 III 8/6/2008 3M INDUSTRIAL ADHESIVES TAPE DIV "PB009150 AS MANUFACTURED IN MEDINA, OH" 21889 III 8/15/2008 3M INDUSTRIAL ADHESIVES TAPE DIV "FP036002 AS MANUFACTURED IN MEDINA, OH" 21890 III 8/1/2008 SOLVIN SA "DIOFAN® A-740 AS MANUFACTURED IN TAVAUX, FRANCE" 21891 II 8/12/2008 TIANJIN PACIFIC CHEMICAL AND PHARMACEUTICAL CO LTD "METFORMIN HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN TIANJIN, CHINA" 21892 II 8/18/2008 MSN PHARMACHEM PVT LTD "ATORVASTATIN CALCIUM (FORM-I) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21893 II 8/14/2008 UNIMARK REMEDIES LTD "MONTELUKAST SODIUM (NI) AS MANUFACTURED IN VALSAD, GUJARAT, INDIA" 21894 II 8/20/2008 SANDOZ INDUSTRIAL PRODUCTS SPA "MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATE AS MANUFACTURED IN ROVERETO (TRENTO), ITALY" 21895 II 8/8/2008 SOLMAG SPA "FLUOXETINE HCL EP/USP AS MANUFACTURED IN GARBAGNATE MILANESE (MI), ITALY " 21896 II 8/13/2008 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD "CLINDAMYCIN PALMITATE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA" 21897 IV 8/11/2008 MASTERTASTE SPA "58.4108.UL PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY" 21898 III 8/11/2008 AMPACET CORP "612249-PT WHITE PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN" 21900 II 9/27/2008 SUN PHARMACEUTICAL INDUSTRIES LTD "TAMSULOSIN HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA" 21901 II 9/28/2008 SUN PHARMACEUTICAL INDUSTRIES LTD "ANASTROZOLE AS MANUFACTURED IN MAHARASHTRA, INDIA" 21902 II 8/21/2008 VITALIFE LABORATORIES (DIV ARCH PHARMALABS LTD) "STAVUDINE USP AS MANUFACTURED IN HARYANA, INDIA" 21903 IV 8/20/2008 MASTERTASTE SPA "30109.1 DRYCELL CITRON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY" 21904 IV 8/20/2008 MASTERTASTE SPA "20.4562.4P PHA ORANGE FLAVOUR AS MANUFACTURED IN TORINO, ITALY" 21905 III 8/21/2008 NYPRO INC "METERED DOSE INHALER, CONTAINER CLOSURE FOR: PRESS AND BREATH CAPPED ACTUATOR AS MANUFACTURED IN BRAY, COUNTY DUBLIN, IRELAND" 21906 II 7/30/2008 ONO PHARMACEUTICAL CO LTD "PROSTAGLANDIN E1 AS MANUFACTURED IN HYOGO, JAPAN BY FUJIMOTO CHEMICALS CO., LTD. FOR ONO PHARMACEUTICAL" 21907 II 8/21/2008 CONCORD BIOTECH LTD "MYCOPHENOLATE SODIUM AS MANUFACTURED IN AHMEDABAD, INDIA" 21908 III 8/14/2008 RICON COLORS INC "GREEN TINT, CPT-G4366-1 AS MANUFACTURED IN WEST CHICAGO, IL" 21909 II 8/11/2008 INDOCO REMEDIES LTD "CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN RAIGAD, INDIA" 21910 II 8/27/2008 HETERO DRUGS LTD "DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21911 II 8/27/2008 CALYX CHEMICALS AND PHARMACEUTICALS LTD "LOSARTAN POTASSIUM USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21912 II 8/28/2008 APOTEX PHARMACHEM INC "PANTOPRAZOLE SODIUM SESQUIHYDRATE AS MANUFACTURED IN BRANTFORD, ONTARIO, CANADA " 21913 II 8/28/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD "EPTIFIBATIDE AS MANUFACTURED IN NETANYA, ISRAEL" 21915 II 8/27/2008 KAMUD DRUGS PVT LTD "TRAMADOL HYDROCHLORIDE BP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21916 III 8/19/2008 AMPACET CORP "682240-PT AMBER PET MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN" 21917 II 8/29/2008 APTUIT LAURUS PRIVATE LTD "CISPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21918 II 8/29/2008 APTUIT LAURUS PRIVATE LTD "CARBOPLATIN USP DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21920 II 9/2/2008 MARTEK BIOSCIENCES CORP "DOCOSAHEXAENOIC ACID ACTIVE SINGLE CELL OIL (DHASCO®) 55% AS MANUFACTURED IN KINGSTREE, SC AND WINCHESTER, KY" 21921 II 9/2/2008 DR REDDYS LABORATORIES LTD "CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21922 IV 8/29/2008 CYCLOLAB CYCLODEXTRIN R AND D LABORATORY LTD "BETA-CYCLODEXTRIN-SULFOBUTYLETHER DERIVATIVE AS MANUFACTURED IN BUDAPEST, HUNGARY" 21923 II 8/29/2008 WOCKHARDT LTD "DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA" 21924 II 8/29/2008 "AVECIA BIOTECHNOLOGY, INC." "DPC 1528 (OLIGONUCLEOTIDE ARM), API, AS MANUFACTURED IN MILFORD, MA" 21925 II 8/25/2008 NUTRA SPECIALITIES PRIVATE LTD "WARFARIN SODIUM USP (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21926 II 8/25/2008 NUTRA SPECIALITIES PRIVATE LTD "WARFARIN SODIUM USP (CLATHRATE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21928 II 8/29/2008 CARDINAL HEALTH 414 LLC "SODIUM FLUORIDE F18 INJECTION AS MANUFACTURED IN DUBLIN, OH" 21929 II 9/1/2008 SYNBIAS PHARMA LTD "VINORELBINE TARTRATE AS MANUFACTURED IN DONETSK, UKRAINE" 21931 II 9/4/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD "OLMESARTAN AS MANUFACTURED IN BEER SHEVA, ISRAEL" 21932 II 8/25/2008 HARBIN PHARMACEUTICAL GROUP CO LTD GENERAL PHARMACEUTICAL FACTORY "6 AMINOPENCILLANIC ACID AS MANUFACTURED IN NANGANG, HARBIN" 21933 III 8/31/2008 FUJIMORI KOGYO CO LTD "FILMBYNA**E-5511 BD AS MANUFACTURED IN SHIZUOKA PREF., JAPAN" 21934 II 9/2/2008 AUROBINDO PHARMA LTD "GALANTAMINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21935 II 9/5/2008 CADILA HEALTHCARE LTD "CLONIDINE AS MANUFACTURED IN GUJARAT, INDIA" 21936 II 9/26/2008 RA CHEM PHARMA LTD "VANILLYLAMINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21937 II 9/20/2008 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "ARIPIPRAZOLE (NON-STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA, INDIA" 21939 II 9/5/2008 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG TIOTROPIUM BROMIDE MONOHYDRATE AS MANUFACTURED IN GERMANY 21940 V 9/2/2008 BIOVIGILANT SYSTEMS INC "IMD-A-200-1 AS MANUFACTURED IN TUCSON, AZ" 21941 II 9/4/2008 POLYDRUG LABORATORIES PVT LTD "METOPROLOL TARTRATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21942 II 9/1/2008 ALP PHARM BEIJING CO LTD "4-AA/AOSA AS MANUFACTURED IN BEIJING, CHINA" 21943 II 9/1/2008 ALP PHARM BEIJING CO LTD "CALCIPOTRIENE (CALCIPOTRIOL) AS MANUFACTURED IN BEIJING, CHINA" 21944 II 9/8/2008 ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD "MIFEPRISTONE AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA" 21945 III 9/5/2008 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG "PLASTIC CONTAINER FOR RESPIMAT® AS MANUFACTURED IN INGELHEIM AM RHEIN, GERMANY" 21946 II 3/10/2008 RN LABORATORIES PVT LTD "CHLORHEXIDINE GLUCONATE 20% SOLUTION AS MANUFACTURED IN GUJARAT, INDIA" 21947 II 9/8/2008 RANBAXY LABORATORIES LTD "OLANZAPINE DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA" 21948 II 9/1/2008 SICHUAN SANCHINE SUNNYHOPE PHARMACEUTICAL CO LTD "MELOXICAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA" 21949 II 9/1/2008 ALP PHARM BEIJING CO LTD "ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA" 21950 II 9/1/2008 ALP PHARM BEIJING CO LTD "DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA" 21951 II 9/1/2008 ALP PHARM BEIJING CO LTD "AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE) AS MANUFACTURED IN BEIJING, CHINA" 21952 II 9/5/2008 FORMOSA LABORATORIES INC "MYCOPHENOLIC ACID AS MANUFACTURED IN TAOYUAN, TAIWAN." 21953 II 9/5/2008 DK PHARMA CHEM PVT LTD "HYDRALAZINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 21955 II 9/5/2008 PIERRE FABRE MEDICAMENT PRODUCTION "VINFLUNINE INJECTION AS MANUFACTURED BY PLANTES & INDUSTRIE IN GAILLAC CEDEX, FRANCE" 21956 III 9/5/2008 KUNSTSTOFFWERK KREMSMUNSTER GMBH "PP28 CHILD RESISTANT TAMPER-EVIDENT SCREW CAPS WITH FILLED DESICCANT-INSERT AS MANUFACTURED IN KREMSUMUNSTER, AUSTRIA" 21957 III 8/29/2008 MONDI COATING ZELTWEG GMBH "FLEXIBLE PACKAGING MATERIALS AS MANUFACTURED IN ZELTWEG, AUSTRIA " 21958 II 9/5/2008 MATRIX LABORATORIES LTD "LANTHANUM CARBONATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21959 II 8/15/2008 AMERICAN PEPTIDE CO "COSYNTROPIN TFA SALT PEPTIDE AS MANUFACTURED IN VISTA, CA" 21960 II 8/26/2008 CADILA PHARMACEUTICALS LTD "ATORVASTATIN CALCIUM AS MANUFACTURED IN GUJARAT, INDIA" 21961 II 9/4/2008 ANQIU LUAN PHARMACEUTICAL CO LTD "ACETAMINOPHEN, DC 90 S AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S REPUBLIC OF CHINA" 21962 II 9/9/2008 CADILA PHARMACEUTICALS LTD "NATEGLINIDE FORM B AS MANUFACTURED IN GUJARAT, INDIA" 21963 II 9/5/2008 DISHMAN NETHERLANDS BV "CALCIFEDIOL AS MANUFACTURED IN WEESP, THE NETHERLANDS" 21964 II 9/10/2008 APTUIT LAURUS PRIVATE LTD "EFAVIRENZ DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21965 III 9/5/2008 FORMOSA PLASTICS CORP USA "FORMOLON 690F PVC RESIN AS MANUFACTURED IN POINT COMFORT, TX AND BATON ROUGE, LA" 21968 II 9/5/2008 NANJING LANYA CHEMICAL CO LTD "MAGNESIUM LACTATE DIHYDRATE AS MANUFACTURED BY GAOYOU SUNSHINE BIOCHEM CO., LTD. IN GAOYOU, CHINA" 21969 II 9/11/2008 MATRIX LABORATORIES LTD (NASHIK FDF) "EFAVIRENZ AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21970 II 9/12/2008 CALYX CHEMICALS AND PHARMACEUTICALS LTD "VALPROIC ACID AS MANUFACTURED IN THANE, (MAHARASHTRA), INDIA" 21971 II 9/10/2008 LUPIN LTD "FENOFIBRATE-SLS MIXTURE AS MANUFACTURED IN MAHARASHTRA, INDIA" 21972 II 9/11/2008 FARMABIOS S P A "BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED AS MANUFACTURED IN GROPELLO CAIROLI (PV), ITALY" 21973 III 8/12/2008 ESS DEE ALUMINIUM LTD "NON TOXIC FOOD/PHARMA GRADE ALU ALU LAMINATE, NON TOXIC FOOD/PHARMA GRADE CHILD RESISTANT (CR) FOIL, NON TOXIC FOOD/PHARMA GRADE TROPICALISED LAMINATE AS MANUFACTURED IN NANI DAMAN (U.T.), INDIA " 21976 II 9/13/2008 DR REDDYS LABORATORIES LTD "ESZOPICLONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21977 III 9/11/2008 REXAM PHARMA GMBH "MIRENA® INSERTER AS MANUFACTURED IN NEUENBURG, GERMANY" 21978 II 9/16/2008 SMS PHARMACEUTICALS LTD "NICOTINE POLACRILEX USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 21980 II 9/17/2008 APOTEX PHARMACHEM INC "OLANZAPINE AS MANUFACTURED IN BRANTFORD ON, CANADA" 21981 II 9/8/2008 FARCHEMIA SRL "OLSALAZINE SODIUM AS MANUFACTURED IN TREVIGLIO, ITALY" 21982 II 9/10/2008 QILU ANTIBIOTICS PHARMACEUTICAL CO LTD "CEFAZOLIN SODIUM, STERILE BULK AS MANUFACTURED IN JINAN, CHINA" 21983 II 9/17/2008 EMCURE PHARMACEUTICALS LTD "SODIUM FERRIC GLUCONATE COMPLEX AS MANUFACTURED IN MAHARASHTRA, INDIA" 21984 II 9/16/2008 CSPC OUYI PHARMACEUTICAL CO LTD "INDOMETHACIN AS MANUFACTURED IN SHIJIAZHUANG, CHINA" 21985 II 9/15/2008 VITALIFE LABORATORIES (DIV ARCH PHARMALABS LTD) "ATORVASTATIN CALCIUM CRYSTALLINE AS MANUFACTURED IN HARYANA, INDIA" 21990 II 9/26/2008 JUBILANT ORGANOSYS LTD "PINAVERIUM BROMIDE AS MANUFACTURED IN KARNATACA, INDIA" 21991 II 7/17/2008 AJINOMOTO INTERAMERICANA IND E COM LTDA "L-ISOLEUCINE AS MANUFACTURED IN LIMERIA, BRAZIL " 21992 III 9/1/2008 ANSA PRINTPACK PVT LTD "PRINTED CARTONS AND PRINTED LABELS AND LEAFLETS AS MANUFACTURED IN THANE, MAHARASHTRA, INDIA" 21993 II 9/15/2008 NEWCHEM SPA "MOMETASONE FUROATE MICRONIZED AS MANUFACTURED IN VERONA, ITALY" 21995 V 9/19/2008 GE HEALTHCARE INC "FASTLAB PET SYNTHESIZER AS MANUFACTURED IN LONCIN, BELGIUM" 21996 V 9/2/2008 BIOVIGILANT SYSTEMS INC "IMD-A-220-4 AS MANUFACTURED IN TUCSON, AZ" 21997 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-100 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 21998 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-105 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 21999 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-110 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22000 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-115 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22001 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-120 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22002 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-125 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO " 22003 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-130 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22004 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-135 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22005 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-140 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22006 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-145 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22007 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-150 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22008 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-155 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22009 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-160 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22010 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-160 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22011 III 9/16/2008 TEKNOR APEX CO "MEDALIST MD-170 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22012 III 9/17/2008 TEKNOR APEX CO "MEDALIST MD-175 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22013 III 9/17/2008 TEKNOR APEX CO "MEDALIST MD-180 NATURAL AS MANUFACTURED BY QST INC. AND TEKNOR PERFORMANCE ELASTOMERS IN SAINT ALBANS, VT AND HENDERSON, KY FOR TEKNOR APEX CO" 22014 II 8/28/2008 JIANGSU ZW PHARMACEUTICALS CO LTD "CAPECITABINE AS MANUFACTURED IN JIANGSU, P.R. CHINA" 22015 II 9/19/2008 JIANGSU HENGRUI MEDICINE CO LTD "GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU, CHINA" 22016 III 9/19/2008 WEST PHARMACEUTICAL SERVICES INC "DAIKYO CRYSTAL ZENITH RU SYRINGE SYSTEM AS MANUFACTURED IN JERSEY SHORE, PA; MONTGOMERY, PA; AND SAN DIEGO, CA" 22017 II 9/19/2008 CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD "CHLOROTHIAZIDE AS MANUFACTURED IN INNER MONGOLIA, CHINA" 22018 II 9/19/2008 MERCIAN CORP "EPIRUBICIN HYDROCHLORIDE AS MANUFACTURED IN KUMAMOTO, JAPAN" 22021 II 9/23/2008 DR REDDYS LABORATORIES LTD "DARIFENACIN HYDROBROMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 22022 II 9/19/2008 "NOVUS FINE CHEMICALS, LLC" "VENLAFAXINE HYDROCHLORIDE AS MANUFACTURED IN CARLSTADT, NJ" 22023 II 9/22/2008 DISHMAN PHARMACEUTICALS AND CHEMICALS LIMITED "ROPIVACAINE HYDROCHLORIDE ANHYDROUS AS MANUFACTURED IN AHMEDABAD, GUJARAT, INDIA" 22024 II 9/24/2008 DR REDDYS LABORATORIES LTD "CARVEDILOL PHOSPHATE (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 22025 II 9/22/2008 BD BIOSCIENCES - ADVANCED BIOPROCESSING "BD CELL MAB MEDIUM BASE W/O PHENYL RED AS MANUFACTURED BY BD DIAGNOSTICS AND SAFC BIOSCIENCES IN SPARKS, MD AND DENVER, PA FOR BD BIOSCIENCES-ADVANCED BIOPROCESSING" 22026 II 9/26/2008 BIAL PORTELA CA SA "ESLICARBAZEPINE ACETATE DRUG SUBSTANCE AS MANUFACTURED BY DOTTIKON EXCLUSIVE SYNTHESIS AG IN DOTTIKON, SWITZERLAND FOR BIAL PORTELA & CA SA" 22027 II 9/24/2008 CADILA HEALTHCARE LTD "HYDROCHLOTHIAZIDE AS MANUFACTURED IN GUJARAT, INDIA" 22028 II 9/30/2008 RELIABLE BIOPHARMACEUTICAL CORP "COSYNTROPIN ACETATE AS MANUFACTURED IN ST. LOUIS, MO" 22032 II 9/25/2008 MYLAN DEVELOPMENT CENTRE PRIVATE LTD "ZOFENOPRIL CALCIUM AS MANUFACTURED IN RAIGAD, MAHARASHTRA, INDIA" 22033 II 9/23/2008 CHEMWERTH INC TIAGABINE HYDROCHLORIDE USP AS MANUFACTURED IN SICHUAN CHINA 22034 II 9/18/2008 SPECIALTY ENZYMES AND BIOCHEMICALS CO LACTASE USP AS MANUFACTURED BY ADVANCED ENZYME TECHNOLOGIES LTD IN NASHIK INDIA FOR SPECIALTY ENZYMES AND BIOCHEMICALS CO 22035 IV 9/1/2008 CRODA INC CRODESTA SL 40E (SUCROSE COCOATE) AS MANUFACTURED IN MILL HALL PA 22036 II 9/23/2008 QILU TIANHE PHARMACEUTICAL CO LTD ALPRAZOLAM USP (NON STERILE API) AS MANUFACTURED IN SHANDONG CHINA 22037 II 9/25/2008 DR REDDYS LABORATORIES LTD "SILDENAFIL CITRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 22038 III 9/29/2008 CAPS & CANS "PLASTIC BOTTLES AND CAPS AS MANUFACTURED IN BANGALORE, INDIA" 22039 II 9/28/2008 QILU TIANHE PHARMACEUTICAL CO LTD BUFLOMEDIL HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG CHINA 22040 II 9/29/2008 MALLINCKRODT INC "BENZPHETAMINE HYDROCHLORIDE CODE 9223 AS MANUFACTURED IN ST LOUIS, MO" 22041 II 9/24/2008 CADILA HEALTHCARE LTD "PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA" 22043 II 9/30/2008 CADILA HEALTHCARE LTD "CARVEDILOL (FORM II) AS MANUFACTURED IN ANKLESHWAR, GUJARAT, INDIA" 22044 II 9/30/2008 DR REDDYS LABORATORIES LTD "NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 22045 II 9/19/2008 CTX LIFE SCIENCES PVT LTD "XYLOMETAZOLINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA" 22049 III 9/30/2008 3M DRUG DELIVERY SYSTEMS DIV "MOMETASONE & FORMOTEROL COMBINATION PRODUCT HFA SHORTENED BODY ACTUATOR AS MANUFACTURED BY NYPRO INC. IN DUBLIN, IRELAND FOR 3M DRUG DELIVERY SYSTEMS DIVISION" 22051 III 9/26/2008 DYNIC USA "S2B THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN" 22052 III 9/26/2008 DYNIC USA "S2C THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN" 22053 III 9/26/2008 DYNIC USA "S10 THERMAL TRANSFER RIBBON AS MANUFACTURED IN TOKYO, JAPAN" 22055 III 9/30/2008 POLYONE CORP "CC10106574WE AMBER PET AS MANUFACTURED IN ELK GROVE VILLAGE, IL" 22056 III 9/19/2008 VEDAT TAMPAS HERMETICAS LTDA "CLOSURES AS MANUFACTURED IN EMBU, SAO PAULO, BRAZIL" 22060 II 9/30/2008 CENTAUR CHEMICALS PRIVATE LTD "OXAZEPAM USP AS MANUFACTURED IN MAHARASHTRA, INDIA" 22064 II 9/26/2008 ALEMBIC LTD "BUPROPION HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT, INDIA" 22066 III 9/26/2008 COSTER USA INC "BAG-ON-VALVE (BOV) COMPONENTS AND SYSTEMS AS MANUFACTURED BY COSTER USA, INC. AND COSTER TECHNOLGIE SPECIALI S.P.A. IN SOUTH ELGIN, IL AND CALCERANICA AL LOGO AND CALDONAZZO, ITALY" 22067 III 9/24/2008 ROLLPRINT PACKAGING PRODUCTS INC "RPP# 26-2203 AS MANUFACTURED IN ADDISON, IL" 22070 II 9/30/2008 ELDER PHARMACEUTICALS LTD "TOLFENAMIC ACID AS MANUFACTURED IN MAHARASHTRA STATE, INDIA" 22073 II 8/5/2008 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD "LOSARTAN POTASSIUM (SYNTHESIS II) AS MANUFACTURED IN ZHEJIANG, CHINA" 22076 III 9/23/2008 AMPACET CORP "AMPACET 110070 BLUE WHITE POLYETHYLENE MASTERBATCH AS MANUFACTURED IN TERRE HAUTE, IN; HEATH, OH; CARTERSVILLE, GA; AND DERIDDER, LA" 22081 II 9/29/2008 ZACH SYSTEM SPA "CLOPIDOGREL BISULFATE AS MANUFACTURED BY MALLADI DRUGS & PHARMACEUTICALS LIMITED, UNIT-3 IN TAMIL NADU, INDIA FOR ZACH SYSTEM S.P.A." 22083 II 4/3/2008 AMISHI DRUGS & CHEMICALS LIMITED "SILVER SULFADIAZINE USP AS MANUFACTURED IN GUJARAT, INDIA" 22086 II 9/22/2008 ZHEJIANG HISOAR PHARMACEUTICAL CO LTD CHUANNAN BRANCH "DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA"