4Q2009NEWTEXT DMF # TYPE SUBMIT DATE HOLDER SUBJECT 21988 II 11/10/2009 JUBILANT ORGANOSYS LTD "LANSOPRAZOLE AS MANUFACTURED IN KARNATAKA, INDIA" 22219 II 10/1/2009 IPCA LABORATORIES LTD "LOSARTAN POTASSIUM AS MANUFACTURED IN MADHYA PRADESH, INDIA" 22348 II 12/22/2008 BIOFER S.P.A. HEPARIN SODIUM INJECTION AS MANUFACTURED IN MEDOLLA (MO) ITALY 22796 III 10/31/2009 IMARETCIOGLU LTD CO CLEAR ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY 22797 III 10/31/2009 IMARETCIOGLU LTD CO AMBER ONE POINT CUT (OPC) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY 22798 III 5/8/2009 IMARETCIOGLU LTD CO AMBER COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY 22799 III 5/8/2009 IMARETCIOGLU LTD CO CLEAR COLOUR BREAK (CBR) AMPOUL AS MANUFACTURED IN SAMSUN TURKEY 22908 III 6/26/2009 TRUDELL MEDICAL INTERNATIONAL PACKAGING COMPONENT AS MANUFACTURED IN ONTARIO CANADA 22946 III 6/29/2009 GERRESHEIMER ZARAGOZA SA PLASTIC BOTTLES AND DROPPER BOTTLE SYSTEMS AS MANUFACTURED IN EPILA SPAIN AND MASALVES (VALENCIA) SPAIN 23054 II 8/19/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD DOCETAXEL AS MANUFACTURED IN LERMA EDO DE MEXICO AND SANTHIA (VC) ITALY FOR TEVA PHARMACUETICAL INDUSTRIES LTD 23064 II 8/20/2009 BIOPHARM GMBH RHGDF-5 (RECOMBINANT HUMAN GROWTH/DIFFERENTIATION FACTOR 5) AS MANUFACTURED IN KAWAGOE CITY SAITAMA JAPAN FOR BIOPHARM GMBH 23134 II 10/27/2009 LUPIN LTD ARMODAFINIL AS MANUFACTURED IN MAHARASHTRA INDIA 23143 II 9/25/2009 TAIZHOU CANDORLY SEA BIOCHEMICAL AND HEALTH PRODUCTS CO LTD (TAIZHOU CHINA) (R) -9-[2-(PHOSPHONMETHOXY)PROPYL]ADENINE AN INTERMEDIATE FOR TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA 23166 IV 10/8/2009 ARMARK AUTHENTICATION TECHNOLOGIES LLC EXCIPIENT ON DOSE (EOD) GRADE COVERT MARKERS(CM): A PHYSICAL CHEMICAL IDENTIFIER (PCID) UTILIZED FOR PHARMACEUTICAL BRAND PROTECTION AS MANUFACTURED IN GLEN ROCK PA 23169 II 9/30/2009 CHONGQING CARE LIFE PHARMACEUTICAL CO LTD ALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING PR CHINA 23171 II 10/5/2009 ION EXCHANGE INDIA LTD CHOLESTYRAMINE RESIN USP (INDION 454) AS MANUFACTURED IN GUJARAT INDIA 23176 III 11/11/2009 WEENER EMPIRE PLASTICS LIMITED HIGH DENSITY POLYETHYLENE BOTTLES AS MANUFACTURED IN SILVASSA (UNION TERRITORY OF D&NH) INDIA 23194 II 10/19/2009 CHOONGWAE PHARMA CORP PNB-THIENAMYCIN IMINE AS MANUFACTURED IN GYEONGGI-DO REPUBLIC OF KOREA 23195 III 10/20/2009 TUBETTIFICIO M FAVIA SRL ALUMINIUM COLLAPSIBLE TUBES FOR DRUG PRODUCTS AS MANUFACTURED IN MILANO ITALY 23196 II 10/18/2009 YONEZAWA HAMARI CHEMICALS LTD LULICONAZOLE AS MANUFACTURED IN YAMAGATA JAPAN 23197 IV 10/14/2009 SURETY LABORATORIES INC SURFASIL 1520 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC 23198 IV 10/14/2009 SURETY LABORATORIES INC SURFASIL 1511 AS MANUFACTURED IN CASSOPOLIS MI FOR SURETY LABORATORIES INC 23199 II 11/16/2009 SUN PHARMACEUTICAL INDUSTRIES LTD "ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT INDIA " 23200 II 10/21/2009 ESTEVE QUIMICA SA DICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE AS MANUFACTURED IN CELRA (GIRONA) SPAIN 23201 II 9/18/2009 HUBEI HUANGSHI SHIXING PHARMACEUTICAL CO LTD DEXKETOPROFEN TROMETAMOL AS MANUFACTURED IN HUBEI PROVINCE PR CHINA 23202 IV 10/6/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00138 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY 23203 IV 10/6/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00139 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY 23204 IV 10/6/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00140 SHEFFIELD COATING SYSTEM CM AS MANUFACTURED IN NORWICH NY 23205 II 10/20/2009 TOMITA PHARMACEUTICAL CO LTD MAGNESIUM OXIDE USP LIGHT POWDER AS MANUFACTURED IN TOKUSHIMA JAPAN 23206 II 10/20/2009 INALCO SPA GOS 95 AS MANUFACTURED IN PISTOIA ITALY 23207 II 10/20/2009 SUVEN LIFE SCIENCES LTD ZOLMITRIPTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA 23208 II 10/19/2009 CHEMI S.P.A. BUPROPION HCL FV3307 AS MANUFACTURED IN PATRICA (FR) ITALY 23209 II 10/12/2009 ALP PHARM BEIJING CO LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR ALP PHARM BEIJING CO LTD 23210 III 10/5/2009 STOLZE UNION SRO GLASS PRIMARY PACKAGING AS MANUFACTURED IN HERMANOVA HUT CZECH REPUBLIC 23211 II 10/10/2009 DALIAN ZHEN-AO BIO-TECH CO LTD URIDINE 5' -MONOPHOSPHATE DISODIUM SALT AS MANUFACTURED IN DALIAN CHINA PC 23212 II 10/29/2009 CSL BEHRING LLC ISCOMATRIX ADJUVANT AS MANUFACTURED IN BRADLEY IL 23213 II 10/26/2009 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD TACROLIMUS SD20 AS MANUFACTURED IN SHU-LIN TAIPEI HSIEN TAIWAN 23214 II 10/21/2009 SIEGFRIED LTD NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN SWITZERLAND 23215 II 10/26/2009 HETERO DRUGS LTD RILUZOLE AS MANUFACTURED IN ANDHRA PRADESH INDIA 23216 II 10/21/2009 SHANDONG NEW TIME PHARMACEUTICAL CO LTD "DILUTED ISOSORBIDE MONONITRATE (60%) AS MANUFACTURED IN SHANDONG PROVINCE CHINA " 23217 II 10/21/2009 SHANDONG NEW TIME PHARMACEUTICAL CO LTD DILUTED ISOSORBIDE MONONITRATE (70%) AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA 23218 IV 10/23/2009 HENKEL CORP DURO-TAK 87-612A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC 23219 II 10/20/2009 DISHMAN PHARMACEUTICALS CHEMICALS LTD OMEPRAZOLE AS MANUFACTURED IN GAJARAT INDIA 23220 II 10/27/2009 EMCURE PHARMACEUTICALS LTD IRINOTECAN HYDROCHLORIDE TRIHYDRATE AS MANUFACTURED IN MAHARASHTRA INDIA 23221 IV 10/29/2009 FONA INTERNATIONAL INC "815.0033U BUBBLEGUM FLAVOR, ART AS MANUFACTURED IN GENEVA IL" 23222 II 10/28/2009 LEK PHARMACEUTICALS DD CASPOFUNGIN ACETATE AS MANUFACTURED IN MENGES SLOVENIA 23223 II 10/29/2009 CHANGZHOU PHARMACEUTICAL FACTORY "RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE) AS MANUFACTURED IN JIANGSU PROVINCE CHINA" 23224 II 10/29/2009 DELMAR CHEMICALS INC SUCCINYLCHOLINE CHLORIDE AS MANUFACTURED IN QUEBEC CANADA 23225 III 10/23/2009 FOUR M PROPACK PVT LTD "BOTTLES AND CLOSURES AS MANUFACTURED IN HIMACHAL PRADESH INDIA " 23226 II 10/29/2009 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA PHENYTOIN AS MANUFACTURED IN COMPOVERDE DI APRILIA (LT) ITALY 23227 II 10/23/2009 DAISO CO LTD "DAISOGEL ODS SERIES CHEMICALLY MODIFIED SILICA GEL AS MANUFACTURED IN HYOGO JAPAN " 23228 II 10/16/2009 CHANGZHOU AHK TECH INC CLADRIBINE NON-STERILE BULK DRUG AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA 23229 III 10/28/2009 HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD SORB OO - OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND JIANG SU PROV CHINA FOR HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD 23230 III 10/30/2009 AMPACET CORP "102837 DESICCANT PE MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH" 23231 III 10/30/2009 COLORS FOR PLASTICS INC THERMOPLASTIC RESIN COLORANT MASTERBATCH R29213 RED AS MANUFACTURED IN ELK GROVE VILLAGE IL AND SPARTANBURG SC 23232 II 10/30/2009 GLAND PHARMA LTD DEXMEDETOMEDINE HYDROCHLORIDE AS MANUFACTURED IN HYDERABAD INDIA 23234 II 10/23/2009 CADILA HEALTHCARE LTD ESCITALOPRAM OXALATE (FORM -1) AS MANUFACTURED IN GUJARAT INDIA 23235 II 10/30/2009 MCGUFF PHARMACEUTICALS INC ASCOR L 500? (ASCORBIC ACID INJECTION USP) AS MANUFACTURED IN SANTA ANA CA 23236 III 10/29/2009 HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD O-BUSTER® OXYGEN ABSORBERS AS MANUFACTURED IN TAICHUNG COUNTY TAIWAN AND JIANG SU PROV. CHANG SHU CHINA 23237 II 10/23/2009 COVALENT LABORATORIES PRIVATE LTD CEFUROXIME AXETIL USP (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23238 III 11/2/2009 TOPAN PRINTING CO LTD HP-3 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATHCES AS MANUFACTURED IN FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD 23239 II 11/2/2009 FINE CHEMICALS CORP (PTY) LTD ROPIVACAINE AS MANUFACTURED IN CAPE TOWN SOUTH AFRICA 23240 II 10/30/2009 ZACH SYSTEM SPA OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN LONIGO ITALY 23241 II 11/2/2009 AREVIPHARMA GMBH BISOPROLOL FUMARATE AS MANUFACTURED IN RADEBEUL GERMANY 23242 II 11/3/2009 IPC PROCESS-CENTER GMBH AND CO KG "IBUPROFEN DC100 (IBUPROFEN PH. EUR., GRANULATED) AS MANUFACTURED IN DRESDEN GERMANY" 23243 II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO LTD DICLOFENAC SODIUM EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN PROVINCE CHINA 23244 II 11/2/2009 HAINAN POLY PHARMACEUTICAL CO LTD THEOPHYLLINE EXTENDED RELEASE CAPSULES AS MANUFACTURED IN HAINAN PROVINCE CHINA 23245 II 12/24/2009 LUPIN LTD RANOLAZINE (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA 23246 II 11/6/2009 PHARMACOSMOS AS 24% IRON ISOMALTOSIDE POWDER AS MANUFACTURED IN HOLBAEK DENMARK 23247 II 11/5/2009 MALLADI DRUGS AND PHARMACEUTICALS LTD LORAZEPAM AS MANUFACTURED IN TAMIL NADU INDIA 23248 II 11/9/2009 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD DINOPROST AS MANUFACTURED IN BUDAPEST HUNGARY 23249 II 11/9/2009 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD MISOPROSTOL AS MANUFACTURED IN BUDAPEST HUNGARY 23250 II 11/5/2009 MOEHS IBERICA SL FENOFIBRATE AS MANUFACTURED IN BARCELONA SPAIN 23251 II 11/4/2009 RA CHEM PHARMA LTD LAMOTRIGINE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 23252 II 12/2/2009 ACOM CORP (ADVANCED CENTER ONCOLOGY MACERATA) SODIUM [124I] IODIDE AS MANUFACTURED IN MONTECOSARO ITALY 23253 III 11/5/2009 PRESSPART NEMO PACKAGING MATERIAL AS MANUFACTURED IN TARRAGONA SPAIN 23254 II 11/5/2009 UNIMARK REMEDIES LTD LANTHANUM CARBONATE OCTAHYDRATE AS MANUFACTURED IN GUJARAT INDIA 23255 II 11/11/2009 MSN LABORATORIES LTD BOSENTAN AS MANUFACTURED IN ANDHRA PRADESH INDIA 23256 II 11/10/2009 DR REDDYS LABORATORIES LTD LOPINAVIR AS MANUFACTURED IN ANDHRA PRADESH INDIA 23257 IV 11/12/2009 COREL PHARMACHEM "ACRYFLOW L, '12-HYDROXY STEARATE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA " 23258 IV 11/11/2009 COREL PHARMACHEM "KYRON T-104, CROSS-LINKED POLYACRYLATE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA " 23259 IV 11/12/2009 COREL PHARMACHEM "ACRYSOL K-150, PROPERITARY MIXTURE AS MANUFACTURED IN DIST MEHSANA (NG) INDIA " 23260 IV 11/12/2009 COREL PHARMACHEM "ACRYSOL EL-135, POLYOXYL 35 CASTOR OIL USP/NF AS MANUFACTURED IN DIST MEHSANA (NG) INDIA " 23261 IV 11/11/2009 COREL PHARMACHEM "KYRON T-114, POLACRILLIC ACID AS MANUFACTURED IN DIST MEHSANA (NG) INDIA " 23262 II 10/28/2009 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD LAMOTRIGINE USP AS MANUFACTURED IN ZHEJIANG CHINA 23263 III 11/12/2009 MYLAN TECHNOLOGIES INC MEDIDERM® 3900 AS MANUFACTURED IN ST ALBANS VT 23264 II 11/11/2009 CADILA HEALTHCARE LTD ATORVASTATIN CALCIUM (CRYSTALLINE) AS MANUFACTURED IN GUJARAT INDIA 23265 II 11/10/2009 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD RIVASTIGMINE HYDROGEN TARTRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA 23266 III 11/12/2009 ST GOBAIN PERFORMANCE PLASTICS F1570 AND F1571 AS MANUFACTURED IN POESTENKILL NY 23267 II 11/13/2009 FORMOSA LABORATORIES INC CALCIPOTRIOL MONOHYDRATE AS MANUFACTURED IN TAOYUAN TAIWAN 23268 II 11/13/2009 FIDIA FARMACEUTICI SPA CHOLINE FENOFIBRATE AS MANUFACTURED IN MULAZZANO (LO) ITALY 23269 II 11/12/2009 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD DARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA 23270 II 11/16/2009 SIFAVITOR SRL PROGUANIL HYDROCHLORIDE AS MANUFACTURED IN LODI ITALY 23271 II 11/4/2009 "SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO, LTD." EFAVIRENZ AS MANUFACTURED IN SHANGHAI CHINA 23272 II 11/9/2009 S M HERBALS PVT LTD 10 DEACETYLBACCATIN III AS MANUFACTURED IN RAJASTHAN INDIA 23273 II 10/27/2009 SHOUGUANG FUKANG PHARMACEUTICAL CO LTD METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE PR CHINA 23274 II 11/17/2009 HETERO DRUGS LTD EPROSARTAN MESYLATE AS MANUFACTURED IN ANDHRA PRADESH INDIA 23276 II 11/24/2009 SUZHOU HOMESUN WANQING PHARMACEUTICAL CO LTD "MEROPENEM FOR INJECTION STERILE BULK (ESUB) AS MANUFACTURED IN JIANGSU PR CHINA " 23277 III 11/16/2009 PACUR LLC "PACKAGING MATERIAL (EXTRUDED PLASTIC SHEET MATERIALS) AS MANUFACTURED IN OSHKOSH WI " 23278 II 11/16/2009 BIOCON LTD PIOGLITAZONE HYDROCHLORIDE AS MANUFACTURED IN BANGALORE INDIA 23279 II 11/18/2009 LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD ACARBOSE AS MANUFACTURED IN GUANGDONG PROVINCE PR CHINA 23280 II 11/16/2009 HIKMA PHARMACEUTICALS NICARDIPINE HYDROCHLORIDE AS MANUFACTURED IN AMMAN JORDAN 23281 II 11/19/2009 HARMAN FINOCHEM LTD FENOFIBRATE USP AS MANUFACTURED IN MAHARASHTRA INDIA 23282 II 11/16/2009 CHANGZHOU SUNLIGHT MEDICAL RAW MATERIAL CO LTD BENZOCAINE USP NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN JIANGSU PROVINCE CHINA 23284 II 12/9/2009 TARO PHARMACEUTICAL INDUSTRIES LTD MEPROBAMATE USP (ESUB) AS MANUFACTURED IN HAIFA BAY ISRAEL 23285 II 12/24/2009 BIOSENSORS INTERNATIONAL BIOLIMUS A9 ACTIVE PHARMACEUTICAL INGREDIENT (API) (ESUB) AS MANUFACTURED IN GUNMA JAPAN FOR BIOSENSORS INTERNATIONAL 23286 III 11/20/2009 TAKEUCHI PRESS INDUSTRIES CO LTD TAKEUCHI 4315F TUBE AS MANUFACTURED IN HYOGO JAPAN 23287 II 11/20/2009 RIBBON SRL AMPICILLIN SODIUM STERILE AS MANUFACTURED IN VILLADOSE (ROVIGO) ITALY 23288 II 11/20/2009 APICORE LLC DISULFIRAM USP AS MANUFACTURED IN GUJARAT INDIA FOR APICORE LLC 23289 II 11/20/2009 RAKSHIT DRUGS PVT LTD WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 23290 IV 11/20/2009 SYMRISE GMBH AND CO KG CYCLOPENTADECANOLIDE (CPD) AS MANUFACTURED IN HOLZMINDEN GERMANY 23291 II 12/15/2009 SUN PHARMACEUTICAL INDUSTRIES LTD QUETIAPINE FUMARATE AS MANUFACTURED IN MAHARASHTRA INDIA 23292 II 12/24/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "QUETIAPINE FUMARATE (NON STERILE BULK API) AS MANUFACTURED IN MAHARASHTRA INDIA " 23293 II 12/28/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD SODIUM CARBONATE (STERILE) AS MANUFACTURED IN ALATHUR INDIA 23294 II 12/24/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "CEFTAZIDIME (STERILE) AS MANUFACTURED IN ALATHUR INDIA " 23295 II 12/29/2009 ORCHID CHEMICALS AND PHARMACEUTICALS LTD "CEFTAZIDIME + SODIUM CARBONATE (STERILE BULK) (ESUB) AS MANUFACTURED IN TAMILNADU INDIA " 23296 IV 11/10/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00149 SHEFFIELD COATING SYSTEM WHITE S AS MANUFACTURED IN NORWICH NY 23297 IV 11/10/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00161 SHEFFIELD COATING SYSTEM WHITE 03 AS MANUFACTURED IN NORWICH NY 23298 IV 11/10/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00162 SHEFFIELD COATING SYSTEM CLEAR PG AS MANUFACTURED IN NORWICH NY 23299 IV 11/10/2009 KERRY BIOFUNCTIONAL INGREDIENTS 5X00169 SHEFFIELD COATING SYSTEM WHITE PG AS MANUFACTURED IN NORWICH NY 23300 II 11/18/2009 ALEMBIC LTD API DIV ARIPIPRAZOLE AS MANUFACTURED IN GUJARAT INDIA 23301 II 11/4/2009 JIANGSU ZW PHARMACEUTICALS CO LTD 4-(TRIFLUOROMETHOXY) ANILINE AS MANUFACTURED IN JIANGSU PROVINCE PR CHINA 23302 II 11/23/2009 FLAMMA SPA LOSARTAN POTASSIUM AS MANUFACTURED IN BERGAMO ITALY 23303 III 11/20/2009 FUJIMORI KOGYO CO LTD RELEASE LINER FILM FOR USE IN PATCHES TRANSDERMAL DRUG DELIVERY (FILMBYNA **E-5511 DG-2.5) AS MANUFACTURED IN SHIZUOKA PREF JAPAN 23304 III 11/11/2009 TRUDELL MEDICAL INTERNATIONAL TOP MOUNTED ACTUATION INDICATOR (TMAI) AS MANUFACTURED IN ONTARIO CANADA 23305 II 11/25/2009 SANDOZ PRIVATE LTD IMIPENEN STERILE AS MANUFACTURED IN MAHARASHTRA INDIA 23306 V 11/21/2009 SANDOZ PRIVATE LTD STERILIZATION PROCESS VALIDATION INFORMATION FOR CARBAPENEM STERILE PRODUCTS LOCATED IN MAHARASHTRA INDIA 23307 II 11/24/2009 SANDOZ GMBH CILASTATIN SODIUM STERILE AS MANUFACTURED IN LANGKAMPFEN AUSTRIA 23310 II 12/10/2009 USV LTD "ACITRETIN USP (ESUB) AS MANUFACTURED IN MAHARASHTRA INDIA " 23311 II 11/20/2009 RPG LIFE SCIENCES LTD HALOPERIDOL USP AS MANUFACTURED IN NAVI MUMBAI INDIA 23312 II 11/25/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD CARVEDILOL PHOSPHATE AS MANUFACTURED IN NETANYA ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD 23313 II 11/24/2009 SANDOZ PRIVATE LTD "IMIPENEM AND CILASTATIN STERILE BLEND AS MANUFACTURED IN MAHARASHTRA INDIA " 23314 II 11/27/2009 PHARMACEUTICAL WORKS POLPHARMA SA ARIPIPRAZOLE AS MANUFACTURED IN STAROGARD GDANSKI POLAND 23315 II 11/27/2009 ITF CHEMICAL LTDA MOXIFLOXACIN HYDROCHLORIDE AS MANUFACTURED IN BAHIA BRAZIL 23316 III 10/7/2009 EMA PHARMACEUTICALS PACKAGING MATERIAL (13 & 20 MM COMBINATED PLASTIC ALUMINUM CAPS) AS MANUFACTURED IN LAILLY EN VAL FRANCE 23317 III 11/26/2009 FUJIMORI KOGYO CO LTD PLASTIC FILM FOR USE IN DRUG PRODUCT CONTAINER AS MANUFACTURED IN MIE PREFECTURE JAPAN 23318 III 11/24/2009 TOPPAN PRINTING CO LTD HP-2 PACKAGE FOR TRANSDERMAL DRUG DELIVERY PATCHES AS MANUFACTURED IN FUKUOKA JAPAN FOR TOPPAN PRINTING CO LTD 23319 II 11/1/2009 CHEMPACIFIC CORP BGP32269 AS MANUFACTURED IN BALTIMORE MD AND ZHEJIANG CHINA FOR CHEMPACIFIC CORPORATION 23320 III 11/28/2009 ESSEL PROPACK LTD (SILVASA UNIT) LAMINATED TUBES AS MANUFACTURED IN DADRA & NAGAR HAVELI INDIA 23321 II 12/10/2009 KREATIVE ORGANICS (P) LTD LAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN PUNJAB INDIA 23322 II 11/30/2009 MATRIX LABORATORIES LTD VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23324 II 12/1/2009 YMC CO LTD YMC BIOPRO SERIES AS MANUFACTURED IN ISHIKAWA JAPAN FOR YMC CO LTD 23325 II 12/1/2009 CILAG AG NALTREXONE HYDROCHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN SWITZERLAND 23326 II 12/1/2009 APOTEX PHARMACHEM INC ANASTROZOLE USP AS MANUFACTURED IN ONTARIO CANADA 23327 II 12/1/2009 CHANGHAI SUNVE PHARMACEUTICAL CO LTD ATENOLOL AS MANUFACTURED IN SHANGHAI PR CHINA 23328 II 12/1/2009 PHARMAZELL GMBH CARBAMAZEPINE (PROCESS II) AS MANUFACTURED IN RAUBLING FEDERAL REPUBLIC GERMANY 23329 II 11/30/2009 EXCELLA GMBH AZATHIOPRINE AS MANUFACTURED IN FEUCHT GERMANY 23330 II 11/25/2009 NINGBO TEAM PHARMACEUTICAL CO LTD ONDANSETRON HYDROCHLORIDE BULK FORM AS MANUFACTURED IN ZHEJIANG PROVINCE PR CHINA 23331 V 12/2/2009 FACTA FARMACEUTICI SPA STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN TERAMO ITALY 23332 II 12/3/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD PALONOSETRON HYDROCHLORIDE FORM A AS MANUFACTURED IN OPAVA KOMAROV CZECH REPUBLIC FOR TEVA PHARMACEUTICAL INDUSTRIES LTD 23334 IV 12/3/2009 DAIDO CHEMICAL CORP SANGELOSE (HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER) AS MANUFACTURED IN OSAKA JAPAN 23335 II 12/2/2009 LONZA AG VOCLOSPORIN (IE-001) AS MANUFACTURED IN VISP SWITZERLAND 23336 II 12/4/2009 AIR LIQUIDE HEALTHCARE AMERICA CORP 80PPM NITROGEN DIOXIDE BALANCE OXYGEN AS MANUFACTURED IN PLUMSTEADVILLE PA 23337 II 12/4/2009 AIR LIQUIDE HEALTHCARE AMERICA CORP 80PPM NITROGEN DIOXIDE BALANCE AIR AS MANUFACTURED IN PLUMSTEADVILLE PA 23339 II 12/4/2009 EMCURE PHARMACEUTICALS LTD GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA INDIA 23340 III 12/3/2009 HPT HOCHWERTIGE PHARMATECHNIK GMBH CO KG HD-PE ROUND BOTTLE 35ML AS MANUFACTURED IN NEUHAUS A RWG GERMANY 23341 II 11/28/2009 QILU PHARMACEUTICAL CO LTD PEMETREXED DISODIUM AS MANUFACTURED IN JINAN SHANDONG PROVINCE PEOPLES REPUBLIC OF CHINA 23342 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD PREGABALIN AS MANUFACTURED IN ZHEJIANG CHINA 23343 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD IMATINIB MESYLATE AS MANUFACTURED IN ZHEJIANG CHINA 23344 V 12/3/2009 SANOFI AVENTIS DEUTSCHLAND GMBH FRANKFURT H600 ASEPTIC PROCESSING FACILITY LOCATED IN FRANKFURT AM MAIN GERMANY 23345 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG CHINA 23346 II 11/30/2009 ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD RIVASTIGMINE TARTRATE AS MANUFACTURED IN ZHEJIANG CHINA 23347 II 12/7/2009 APOTEX PHARMACHEM INC IRBESARTAN USP AS MANUFACTURED IN TOLUCA MEXICO FOR APOTEX PHARMACHEM INC (API) 23348 III 11/15/2009 SURYAS OLDFORT PLASTICS PVT LTD "LDPE BASED PLASTIC FILMS FOR PHARMACEUTICAL USE AS MANUFACTURED IN SILVASSA INDIA " 23349 II 11/30/2009 UNIMARK REMEDIES LTD TOPIRAMATE USP (PROCESS A) AS MANUFACTURED IN GUJARAT INDIA 23350 II 12/8/2009 GADOR SA SODIUM IBANDRONATE AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES ARGENTINA 23351 II 11/30/2009 ALEMBIC LTD API DIV QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT INDIA 23352 III 12/4/2009 AMERICHEM INC 44225-CD5 BLUE COLORANT AS MANUFACTURED IN CUYAHOGA FALLS OH 23353 II 11/30/2009 CTX LIFE SCIENCES PVT LTD OXCARBAZEPINE (ROUTE-I) AS MANUFACTURED IN GUJARAT INDIA 23354 II 12/4/2009 MYLAN INDIA PRIVATE LTD BOSENTAN AS MANUFACTURED IN MAHARASHTRA INDIA 23355 II 12/2/2009 SAFC BIOSCIENCES INC EX-CELL® ANTIFOAM GAMMA IRRADIATED BY SER-TAIN® PROCESS AS MANUFACTURED IN DENVER PA 23356 III 12/1/2009 SIBO G DOO CHILD RESISTANT CLOSURE CRP-045-FP AS MANUFACTURED IN SKOFJA LOKA SLOVENIA EU 23357 III 12/7/2009 ESSEL PROPACK LTD (GOA UNIT) LAMINATED TUBES AS MANUFACTURED IN GOA INDIA 23358 II 12/4/2009 NORTH CHINA PHARMACEUTICAL HUASHENG CO LTD BACITRACIN ZINC NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN HEBEI CHINA 23359 II 12/7/2009 JOST CHEMICAL CO POTASSIUM NITRATE AS MANUFACTURED IN ST LOUIS MO 23360 II 12/10/2009 SANOFI AVENTIS DEUTSCHLAND GMBH FEXOFENADINE HYDROCHLORIDE (MDL 16455 A) AS MANUFACTURED IN FRANKFURT AM MAIN GERMANY 23361 II 11/30/2009 ZHEJIANG GARDEN BIOCHEMICAL HIGH TECH STOCK CO LTD CHOLECALCIFEROL AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA 23362 II 12/11/2009 CBL - CHATHAM BIOTEC LTD SEMISYNTHETIC DOCETAXEL DRUG SUBSTANCE (API) AS MANUFACTURED IN SHANGHAI CHINA (MAINLAND) FOR CBL - CHATHAM BIOTEC LTD 23363 IV 12/7/2009 HENKEL CORP DURO-TAK 87-625A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC 23364 IV 12/7/2009 HENKEL CORP DURO-TAK 87-626A PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY NC 23365 II 12/8/2009 BIOCON LTD TACROLIMUS (PRODUCT CODE 8000255) AS MANUFACTURED IN BANGALORE INDIA 23367 II 12/14/2009 MATRIX LABORATORIES LIMITED PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH INDIA 23368 II 12/14/2009 MATRIX LABORATORIES LIMITED NEVIRAPINE ANHYDROUS USP (RAN) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23369 II 1/6/2010 EQUATEQ LTD "OMEGA-3 ACID ETHYL ESTERS 90 (ESUB) AS MANUFACTURED IN ISLE OF LEWIS, SCOTLAND UK" 23370 III 11/11/2009 STE PHARMAPACK SL PLASTIC MOLDED BOTTLE ASSEMBLIES FOR PACKAGING AND DELIVERY OF PHARMACEUTICAL PRODUCTS AS MANUFACTURED IN TARRAGONA SPAIN 23372 II 12/15/2009 SRI KRISHNA DRUGS LTD MECLIZINE HYDROCHLORIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 23373 II 11/23/2009 COVALENT LABORATORIES PRIVATE LTD 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVNA) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23374 II 12/16/2009 GADOR SA "ZOLEDRONIC ACID AS MANUFACTURED IN PILAR PROVINCIA DE BUENOS AIRES ARGENTINA " 23375 II 12/8/2009 SCORA SA "GRANULAR CALCIUM CARBONATE (SCORALITE DC AND SCORALITE LOW LEAD DC) AS MANUFACTURED IN CAFFIERS FRANCE " 23376 II 12/15/2009 SANOFI CHIMIE RPR106721 - POMA (INTERMEDIATE) AS MANUFACTURED IN VERTOLAYE FRANCE 23377 III 12/15/2009 MGJ (MANUFACTURE GENERALE DE JOINTS) CORESEAL® LINERS AS MANUFACTURED IN CHAZAY D'AZERGUES FRANCE 23378 II 12/16/2009 SHASUN CHEMICALS AND DRUGS LIMITED COLESEVELAM HYDROCHLORIDE AS MANUFACTURED IN CUDDALORE INDIA 23379 II 12/16/2009 HETERO DRUGS LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA 23380 II 12/16/2009 AMINO CHEMICALS LTD DEXLANSOPRAZOLE AS MANUFACTURED IN MARSA MALTA 23381 II 12/17/2009 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD ROSIGLITAZONE MALEATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA 23382 II 12/17/2009 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD LEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA 23383 II 12/17/2009 EVERLIGHT CHEMICAL INDUSTRIAL CORP LUBIPROSTONE AS MANUFACTURED IN TAOYUAN HSIEN TAIWAN 23384 V 12/21/2009 SANDOZ GMBH STERILIZATION PROCESS VALIDATION INFORMATION FOR THE STERILE CEPHALOSPORIN CRYSTALLIZATION PLANT LOCATED IN KUNDL TYROL AUSTRIA 23385 II 12/14/2009 SOCHINAZ SA DORZOLAMIDE HYDROCHLORIDE AS MANUFACTURED IN VIONNAZ SWITZERLAND 23386 II 12/21/2009 MITSUBISHI TANABE PHARMA CORP MT-7716 DRUG SUBSTANCE AS MANUFACTURED IN YAMAGUCHI JAPAN FOR MITSUBISHI TANABE PHARMA CORPORATION 23387 II 12/18/2009 SCINOPHARM TAIWAN LTD DECITABINE AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC 23388 II 12/18/2009 CHEMO IBERICA SA MADRID SEVELAMER CARBONATE AS MANUFACTURED IN ZHEJIANG PROVINCE PR OF CHINA FOR CHEMO IBERIC SA MADRID 23390 II 12/18/2009 ARCHIMICA INC CHOLINE FENOFIBRATE DRUG SUBSTANCE AS MANUFACTURED IN SPRINGFIELD MO 23391 III 12/18/2009 JSR CORP ARTON SERIES AS MANUFACTURED IN CHIBA JAPAN 23392 IV 12/18/2009 FONA INTERNATIONAL INC 856.0196U GRAPE FLAVOR ART AS MANUFACTURED IN GENEVA IL 23393 III 12/18/2009 EI DUPONT DE NEMOURS INC "DUPONT APPEEL LIDDING SEALANT RESINS AS MANUFACTURED IN ORANGE TX, ONTARIO CANADA, ZWIJNDRECHT BELGIUM AND HIROSHIMA PREFECTURE JAPAN" 23394 III 12/21/2009 COIM USA INC NOVACOTE NC-9170-23MAC WITH CO-REACTANT CA-350 PU AS MANUFACTURED IN WEST DEPTFORD NJ 23395 V 12/18/2009 NANOINK INC PHARMACEUTICAL BRAND PROTECTION AND ANTI-COUNTERFEITING INSTRUMENTATION AND PROCESS FOR HARD CAPSULES AS MANUFACTURED IN SKOKIE IL 23396 II 12/22/2009 SRI KRISHNA DRUGS LTD FUROSEMIDE USP AS MANUFACTURED IN ANDHRA PRADESH INDIA 23397 II 1/12/2010 LUPIN LTD DROSPIRENONE USP (ESUB) AS MANUFACTURED IN MADHYA PRADESH INDIA FOR LUPIN LIMITED 23400 II 12/15/2009 SYN TECH CHEM AND PHARM CO LTD RABEPRAZOLE SODIUM AS MANUFACTURED IN HSIN-YING TAIWAN ROC 23401 II 12/23/2009 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD RANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA 23402 II 12/23/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD LUBIPROSTONE AS MANUFACTURED IN ZAGREB CROATIA FOR TEVA PHARMACEUTICAL INDUSTRIES LTD 23403 II 12/22/2009 SIEGFRIED USA INC OXYMORPHONE HYDROCHLORIDE USP AS MANUFACTURED IN PENNSVILLE NJ 23405 II 12/22/2009 POLYDRUG LABORATORIES PVT LTD FLUCONAZOLE AS MANUFACTURED IN MAHARASHTRA INDIA 23406 II 12/16/2009 CENWAY PHARMACEUTICALS CO LTD DOCETAXEL AS MANUFACTURED IN TIANJIN PR CHINA 23407 III 12/21/2009 AMPACET CORP "603192-PT UVA PET MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA AND HEATH OH" 23408 II 12/23/2009 THE SUZUKI MENTHOL CO LTD L-MENTHOL USP/JP AS MANUFACTURED IN KOBE JAPAN 23409 II 12/29/2009 MYLAN INDIA PRIVATE LTD VORINOSTAT AS MANUFACTURED IN MAHARASHTRA INDIA 23410 II 12/29/2009 MYLAN INDIA PRIVATE LTD LENALIDOMIDE AS MANUFACTURED IN MAHARASHTRA INDIA 23411 II 12/29/2009 MYLAN INDIA PRIVATE LTD LETROZOLE AS MANUFACTURED IN MAHARASHTRA INDIA 23412 II 12/28/2009 RANBAXY LABORATORIES LTD ENTACAPONE AS MANUFACTURED IN PUNJAB INDIA 23413 II 12/29/2009 RANBAXY LABORATORIES LTD TROSPIUM CHLORIDE (NON-STERILE BULK) AS MANUFACTURED IN PUNJAB INDIA 23414 II 12/29/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD SUNITINIB MALATE AS MANUFACTURED IN MILAN ITALY FOR TEVA PHARMACEUTICAL INDUSTRIES LTD 23415 II 12/15/2009 AANJANEYA BIOTECH PVT LTD QUININE SULPHATE USP DRUG SUBSTANCE AS MANUFACTURED IN MAHAD INDIA 23416 II 12/22/2009 CHEMWERTH INC AZACITIDINE NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR CHEMWERTH INC 23417 II 12/28/2009 CHEMWERTH INC PEMETREXED DISODIUM NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN ZHEJIANG PROVINCE CHINA FOR CHEMWERTH INC 23418 II 12/31/2009 ACS DOBFAR SPA AMPA AS MANUFACTURED IN MILANO ITALY 23420 IV 12/18/2009 DOW CORNING CORPORATION DOW CORNING? Q7-9180 SILICONE FLUIDS AS MANUFACTURED IN HEMLOCK MI 23421 II 12/30/2009 WUHAN GRAND PHARMACEUTICAL GROUP CO LTD METRONIDAZOLE AS MANUFACTURED IN WUHAN CHINA 23422 II 12/29/2009 MACLEODS PHARMACEUTICALS LTD VALACICLOVIR HYDROCHLORIDE DIHYDRATE AS MANUFACTURED IN GUJARAT INDIA 23423 II 12/28/2009 SCINOPHARM TAIWAN LTD TRAVOPROST AS MANUFACTURED IN TAINAN COUNTY TAIWAN ROC 23424 II 12/28/2009 ALP PHARM BEIJING CO LTD "ESZOPICLONE AS MANUFACTURED IN ZHEJIANG CHINA FOR ALP PHARM BEIJING CO LTD " 23425 II 12/29/2009 SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTD SIMVASTATIN NON STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING PR CHINA 23426 II 12/31/2009 "ALEMBIC LIMITED (API DIVISION, KARAKHADI)" DONEPEZIL HYDROCHLORIDE AS MANUFACTURED IN GUJARAT INDIA 23427 II 1/5/2010 INDUSTRIALE CHIMICA SRL FLUTICASONE PROPIONATE AS MANUFACTURED IN SARONNO (VARESE) ITALY 23428 II 1/5/2010 INDUSTRIALE CHIMICA SRL DIENOGEST AS MANUFACTURED IN SARONNO (VARESE) ITALY 23431 II 1/6/2010 MATRIX LABORATORIES LTD LAMIVUDINE USP (SVF) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23432 II 1/6/2010 CADILA HEALTHCARE LTD RANOLAZINE AS MANUFACTURED IN GUJARAT INDIA 23433 II 1/6/2010 CADILA HEALTHCARE LTD GEMCITABINE HYDROCHLORIDE USP AS MANUFACTURED IN GUJARAT INDIA 23434 II 1/6/2010 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD METAXALONE AS MANUFACTURED IN TAIPEI HSIEN TAIWAN 23435 II 1/6/2010 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD MYCOPHENOLATE SODIUM AS MANUFACTURED IN TAIPEI HSIEN TAIWAN 23436 II 12/31/2009 AUROBINDO PHARMA LTD CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA 23437 II 1/4/2010 CERBIOS PHARMA SA CALCIUM LEVOFOLINATE AS MANUFACTURED IN BARBENGO/LUGANO SWITZERLAND 23438 II 12/31/2009 NECTAR LIFESCIENCES LTD 7-AMINO-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (7-AVCA) [NON-STERILE DRUG SUBSTANCE INTERMEDIATE] AS MANUFACTURED IN CHANDIGARH INDIA 23439 II 1/7/2010 CADILA HEALTHCARE LTD CLOPIDOGREL BISULFATE USP (FORM-I) (CUE ROUTE) AS MANUFACTURED IN GUJARAT INDIA 23440 II 1/8/2010 SCI PHARMTECH INC DULOXETINE HYDROCHLORIDE (DULO.HCI) AS MANUFACTURED IN TAOYUAN TAIWAN 23441 II 1/12/2010 MATRIX LABORATORIES LIMITED VARENICLINE TARTRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA 23442 II 1/8/2010 MSN PHARMACHEM PVT LTD SUMATRIPTAN USP [ROUTE CODE SN] AS MANUFACTURED IN ANDHRA PRADESH INDIA 23443 II 1/11/2010 EMCURE PHARMACEUTICALS LTD TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA 23444 II 1/7/2010 PROVENTUS LIFE SCIENCES PRIVATE LIMITED "PRIMIDONE AS MANUFACTURED IN CHENNAI INDIA " 23445 III 1/11/2010 TEIJIN FIBERS LIMITED "POLYETHYLENE TEREPHTHALATE RESIN (TYPE SD-M) AS MANUFACTURED IN EHIME PREF JAPAN " 23446 II 1/8/2010 ALP PHARM BEIJING CO LTD CIDOFOVIR DIHYDRATE AS MANUFACTURED IN SHANDONG CHINA PC FOR ALP PHARM BEIJING CO LTD 23447 III 1/12/2010 TRIMAR INTERNATIONAL CORP HIGH DENSITY POLYETHYLENE (HDPE) BOTTLES AS MANUFACTURED IN YUNLIN COUNTY TAIWAN 22348 III 12/22/2008 BIOFER SPA HEPARIN SODIUM INJECTION AS MANUFACTURED IN MEDOLLA (MO) ITALY 23449 II 1/11/2010 MACLEODS PHARMACEUTICALS LTD IRBESARTAN AS MANUFACTURED IN GUJARAT INDIA 23450 II 1/7/2010 APTUIT LAURUS PRIVATE LTD "TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN ANDHRA PRADESH INDIA " 23453 II 1/11/2010 PARABOLIC DRUGS LTD CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-II AS MANUFACTURED IN PUNJAB INDIA