Page 1

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
23660 II 3/16/2011 CIPLA LTD DARUNAVIR AS MANUFACTURED IN MAHARASHTRA, INDIA
23850 II 2/10/2011 LUPIN LTD DARUNAVIR ETHANOLATE AS MANUFACTURED IN MAHARASHTRA INDIA
ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN WUHAN,
23973 II 8/25/2010 WUHAN WUYAO PHARMACEUTICAL CO LTD CHINA
ATS-8 / (4R-CIS)-1, 1-DIMETHYLETHYL-6-CYANOMETHYL-2,2-DIMETHYL-1,3-DIOXANE-4-ACETATE AS
24069 II 1/12/2011 ARCH PHARMALABS LTD MANUFACTURED IN ANDHRA PRADESH INDIA
24136 II 3/4/2011 SHILPA MEDICARE LTD GEMCITABINE HYDROCHLORIDE AS MANUFACTURED IN KARNATAKA, INDIA
PARALOID RESINS USED AS A COMPONENT IN PHARMACEUTICAL PACKAGING AS MANUFACTURED
24140 III 6/8/2010 ROHM AND HAAS CO IN LOUISVILLE, KY
24157 II 1/27/2011 MALLINCKRODT INC NOSCAPINE USP/EP CRYSTALS CODE 6047 AS MANUFACTURED IN ST LOUIS MO
24207 II 3/4/2011 RELIANCE LIFE SCIENCES PVT LTD IMATINIB MESYLATE AS MANUFACTURED IN NAVI MUMBAI, INDIA
24298 II 12/17/2010 IND SWIFT LABORATORIES LTD TEMOZOLOMIDE AS MANUFACTURED IN PUNJAB INDIA
24337 II 11/5/2010 EXCELLA GMBH GANCICLOVIR ANHYDROUS R AS MANUFACTURED IN FEUCHT GERMANY
24339 II 3/1/2011 GLAXOSMITHKLINE LLC CEFTAZIDIME AS MANUFACTURED IN CUMBRIA, UK FOR GLAXOSMITHKLINE LLC
24411 II 3/1/2011 GLAXOSMITHKLINE LLC CEFUROXIME SODIUM AS MANUFACTURED IN CORK, IRELAND FOR GLAXOSMITHKLINE LLC
24423 II 1/15/2011 SUN PHARMACEUTICAL INDUSTRIES LTD BIVALIRUDIN AS MANUFACTURED IN MAHARASHTRA INDIA
24443 II 2/14/2011 PHF SA QUETIAPINE FUMARATE AS MANUFACTURED IN QUEBEC, CANADA FOR PHF SA
24451 II 12/14/2010 LONZA BRAINE SA SECRETIN DRUG SUBSTANCE AS MANUFACTURED IN BRAINE-L ALLEUD BELGIUM
TOPOTECAN HYDROCHLORIDE AS MANUFACTURED IN CORK, IRELAND FOR GLAXOSMITHKLINE
24458 II 2/2/2011 GLAXOSMITHKLINE LLC LLC
24468 II 2/24/2011 CONCORD BIOTECH LTD SIROLIMIUS AS MANUFACTURED IN AHMEDABAD, INDIA
AMOXICILLIN SODIUM AS MANUFACTURED IN WEST SUSSEX, UNITED KINGDOM FOR
24471 II 2/11/2011 GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE GLAXOSMITHKLINE LLC DBA GLAXOSMITHKLINE
24472 II 1/5/2011 IND SWIFT LABORATORIES LTD TELMISARTAN AS MANUFACTURED IN PUNJAB, INDIA
OVERTUNING DROPPER 0.65 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO
24489 III 12/23/2010 BORMIOLI ROCCO E FIGLIO SPA - BU PLASTICA (PV) ITALY, AND SAINT SULPICE FRANCE
TAMPER EVIDENT CLOSURE 15 MM AS MANUFACTURED IN CASTELGUELFO (PR) ITALY,
24490 III 12/23/2010 BORMIOLI ROCCO E FIGLIO SPA - BU PLASTICA RIVANAZZANO (PV) ITALY, AND SAINT SULPICE FRANCE
LDPE BOTTLE 10 ML AS MANUFACTURED IN CASTELGUELFO (PR) ITALY, RIVANAZZANO (PV) ITALY,
24491 III 12/23/2010 BORMIOLI ROCCO E FIGLIO SPA - BU PLASTICA AND SAINT SULPICE FRANCE
CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MYSORE DIST., INDIA
24496 II 2/21/2011 JUBILANT LIFE SCIENCES LIMITED
24500 II 3/1/2011 PHARMACIA AND UPJOHN CO TESTOSTERONE UNDECANOATE AS MANUFACTURED IN KALAMAZOO, MICHIGAN
24503 II 12/21/2010 MATRIX LABORATORIES LTD DEXLANSOPRAZOLE SESQUIHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24504 II 12/28/2010 MATRIX LABORATORIES LTD ELETRIPTAN HYDROBROMIDE (PROCESS 1) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24505 II 12/21/2010 MATRIX LABORATORIES LTD AMBRISENTAN AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24506 II 12/29/2010 NEULAND LABORATORIES LTD LINEZOLID (FORM-II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24507 II 12/20/2010 SHANDONG FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-EP 3.0) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF CHINA

24508 II 12/20/2010 SHANDONG FREDA BIOPHARM CO LTD SODIUM HYALURONATE (HA-EP 1.8) AS MANUFACTURED IN SHANDONG PROVINCE, P.R. OF CHINA
 Page 2

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
24509 II 12/30/2010 MATRIX LABORATORIES LTD SUNITINIB MALATE AS MANUFACTURED IN MAHARASHTRA, INDIA
24510 II 12/30/2010 SCINOPHARM TAIWAN LTD CLADRIBINE AS MANUFACTURED IN TAINAN, TAIWAN
24511 II 12/30/2010 CHANGZHOU PHARMACEUTICAL FACTORY EZETIMIBE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
24512 III 12/28/2010 AMPACET CORP 502997 AS PE MB AS MANUFACTURED IN MESSANCY, BELGIUM AND TELGATE (BG), ITALY FOR
AMPACET CORP
24514 IV 12/30/2010 SENSIENT FLAVORS LLC NATURAL AND ARTIFICIAL SPRAY DRIED CITRUS TYPE FLAVORS AS MANUFACTURED IN
INDIANAPOLIS, INDIANA
24515 III 12/30/2010 GOPALDAS VISRAM & CO LTD BOTTLES AS MANUFACTURED IN KUNDAIM, GOA, INDIA
24516 II 12/31/2010 DR REDDYS LABORATORIES LTD MONTELUKAST SODIUM [PROCESS-2] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24517 II 1/3/2011 CADILA HEALTHCARE LIMITED CAPECITABINE USP AS MANUFACTURED IN GUJARAT, INDIA
24517 II 1/3/2011 CADILA HEALTHCARE LIMITED CAPECITABINE USP AS MANUFACTURED IN GUJARAT, INDIA
24518 II 12/29/2010 ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL AMIODARONE HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG, CHINA
CO LTD
24519 II 3/22/2011 JUBILANT LIFE SCIENCES LIMITED REPAGLINIDE AS MANUFACTURED IN MYSORE DIST., INDIA
24519 II 3/22/2011 JUBILANT LIFE SCIENCES LIMITED REPAGLINIDE AS MANUFACTURED IN MYSORE DIST., INDIA
24520 II 1/17/2011 AUROBINDO PHARMA LIMITED NEVIRAPINE ANHYDROUS USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24520 II 1/17/2011 AUROBINDO PHARMA LIMITED NEVIRAPINE ANHYDROUS USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24522 II 1/4/2011 CADILA HEALTHCARE LIMITED DICLOFENAC EPOLAMINE AS MANUFACTURED IN GUJARAT, INDIA
24522 II 1/4/2011 CADILA HEALTHCARE LIMITED DICLOFENAC EPOLAMINE AS MANUFACTURED IN GUJARAT, INDIA
24523 II 12/15/2010 DISHMAN PHARMACEUTICALS CHEMICALS LTD BENZOCAINE AS MANUFACTURED IN GUJARAT, INDIA
24523 II 12/15/2010 DISHMAN PHARMACEUTICALS CHEMICALS LTD BENZOCAINE AS MANUFACTURED IN GUJARAT, INDIA
24524 II 1/19/2011 GLENMARK GENERICS LIMITED CHOLINE FENOFIBRATE AS MANUFACTURED IN GUJARAT STATE, INDIA
24524 II 1/19/2011 GLENMARK GENERICS LIMITED CHOLINE FENOFIBRATE AS MANUFACTURED IN GUJARAT STATE, INDIA
24525 II 12/31/2010 SARV BIO LABS PVT LTD COLCHICINE USP AS MANUFACTURED IN HIMACHAL PRADESH, INDIA
24526 II 1/5/2011 ALEMBIC LTD API DIV METOPROLOL TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA
24526 II 1/5/2011 ALEMBIC LTD API DIV METOPROLOL TARTRATE USP AS MANUFACTURED IN GUJARAT, INDIA
CSPC SHIJIAZHUANG GAOKE MEDICAL
24527 II 1/4/2011 TECHNOLOGY DEVELOPMENT CO LTD CEFAZOLIN SODIUM (STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
CSPC SHIJIAZHUANG GAOKE MEDICAL
24527 II 1/4/2011 TECHNOLOGY DEVELOPMENT CO LTD CEFAZOLIN SODIUM (STERILE) AS MANUFACTURED IN HEBEI PROVINCE, P.R. CHINA
24528 II 12/29/2010 FIS FABBRICA ITALIANA SINTETICI SPA ELETRIPTAN HYDROBROMIDE AS MANUFACTURED IN VICENZA, ITALY
24529 II 12/31/2010 QILU TIANHE PHARMACEUTICAL CO LTD CAPECITABINE (NON-STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
PHYTOMENADIONE (VITAMIN K1) AS MANUFACTURED IN SISSELN, SWITZERLAND FOR DSM
24530 II 1/5/2011 DSM NUTRITIONAL PRODUCTS LTD NUTRITIONAL PRODUCTS LTD
PHYTOMENADIONE (VITAMIN K1) AS MANUFACTURED IN SISSELN, SWITZERLAND FOR DSM
24530 II 1/5/2011 DSM NUTRITIONAL PRODUCTS LTD NUTRITIONAL PRODUCTS LTD
ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) AS
24532 II 1/6/2011 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD MANUFACTURED IN TAMIL NADU, INDIA
ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) AS
24532 II 1/6/2011 ACTAVIS PHARMA MANUFACTURING PRIVATE LTD MANUFACTURED IN TAMIL NADU, INDIA
 Page 3

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
24534 III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL CO LTD PCTFE/PVC COMPOSITE SHEET FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN
SUZHOU, P.R. CHINA
24535 III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL CO LTD ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING AS MANUFACTURED IN SUZHOU, P.R. CHINA

24536 III 12/15/2010 SUZHOU HAISHUN PACKAGING MATERIAL CO LTD POLYAMIDE/ALUMINIUM/PVC COLD-FORMED FOIL FOR PHARMACEUTICAL PACKAGING AS
MANUFACTURED IN SUZHOU, P.R. CHINA
24537 II 1/4/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP AS MANUFACTURED IN PUNJAB, INDIA
24537 II 1/4/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL - AMORPHOUS (PROCESS-III) USP AS MANUFACTURED IN PUNJAB, INDIA
24538 II 1/7/2011 CADILA HEALTHCARE LIMITED ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
24538 II 1/7/2011 CADILA HEALTHCARE LIMITED ESOMEPRAZOLE SODIUM AS MANUFACTURED IN GUJARAT, INDIA
24539 III 12/15/2010 PAREKHPLAST INDIA PVT LTD HDPE BOTTLES WITH CAPS AS MANUFACTURED IN MAHARASHTRA, INDIA
24540 II 1/7/2011 MOEHS IBERICA SL CHOLINE FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN FOR MOEHS IBERICA SL
24540 II 1/7/2011 MOEHS IBERICA SL CHOLINE FENOFIBRATE AS MANUFACTURED IN BARCELONA, SPAIN FOR MOEHS IBERICA SL
QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN AND SANTANDER, SPAIN FOR
24541 II 1/7/2011 MOEHS IBERICA SL MOEHS IBERICA SL
QUETIAPINE FUMARATE AS MANUFACTURED IN BARCELONA, SPAIN AND SANTANDER, SPAIN FOR
24541 II 1/7/2011 MOEHS IBERICA SL MOEHS IBERICA SL
24542 II 1/31/2011 USV LTD OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
24542 II 1/31/2011 USV LTD OLOPATADINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
24543 II 1/7/2011 NEWCHEM SPA TRIAMCINOLONE ACETONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY
24543 II 1/7/2011 NEWCHEM SPA TRIAMCINOLONE ACETONIDE MICRONIZED AS MANUFACTURED IN VERONA, ITALY
24544 II 3/2/2011 AUROBINDO PHARMA LIMITED VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24544 II 3/2/2011 AUROBINDO PHARMA LIMITED VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24545 II 12/17/2010 SAFC INC HALOFUGINONE LACTATE AS MANUFACTURED IN MADISON, WI
24546 II 1/12/2011 UQUIFA MEXICO SA DE CV CARISOPRODOL AS MANUFACTURED IN MORELOS, MEXICO
24546 II 1/12/2011 UQUIFA MEXICO SA DE CV CARISOPRODOL AS MANUFACTURED IN MORELOS, MEXICO
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO
24548 II 1/4/2011 LTD LEVALBUTEROL L-TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO
24548 II 1/4/2011 LTD LEVALBUTEROL L-TARTRATE AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
24549 II 12/22/2010 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD TORSEMIDE, USP AS MANUFACTURED IN ZHEJIANG, CHINA
24550 II 12/23/2010 MATRIX LABORATORIES LTD ZIDOVUDINE USP (PROCESS III) AS MANUFACTURED IN ANDHRA PRADESH, INDIA FOR MATRIX
LABORATORIES LTD
TPE W4509 THERMOPLASTIC ELASTOMER COMPOUND FOR VIAL CAPS & CLOSURES AS
24551 III 1/5/2011 BV RUBBERFABRIEK WITTENBURG MANUFACTURED IN THE NETHERLANDS
24552 II 1/15/2011 MACLEODS PHARMACEUTICALS LIMITED RIZATRIPTAN BENZOATE AS MANUFACTURED IN GUJARAT, INDIA
24553 II 1/18/2011 GEDEON RICHTER PLC ESTRADIOL VALERATE AS MANUFACTURED IN BUDAPEST, HUNGARY
120919 SILVER PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA,
24555 III 1/10/2011 AMPACET CORP AND HEATH OH
120937 GOLD PP MB AS MANUFACTURED IN TERRE HAUTE IN, DERIDDER LA, CARTERSVILLE GA,
24556 III 1/10/2011 AMPACET CORP AND HEATH OH
 Page 4

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
24557 II 1/19/2011 HETERO DRUGS LTD CELECOXIB AS MANUFACTURED IN ANDHRA PRADESH, INDIA
CRYSTAL ZENITH (CZ) VIAL READY-TO-USE AS MANUFACTURED IN MONTGOMERY PA, SCOTTSDALE
AZ, LIONVILLE PA, SAN DIEGO CA, AND SALT LAKE CITY UT FOR WEST PHARMACEUTICAL SERVICES
24558 V 1/10/2011 WEST PHARMACEUTICAL SERVICES INC INC
24559 II 1/18/2011 EMCURE PHARMACEUTICALS LTD OXALIPLATIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24560 II 1/19/2011 CARDINAL HEALTH 414 LLC SODIUM ACETATE C-11 INJECTION AS MANUFACTURED IN PHOENIX, AZ
LEVOCETIRIZINE DIHYDROCHLORIDE AS MANUFACTURED IN BLANSKO, CZECH REPUBLIC FOR
24561 II 1/19/2011 SYNTHON BV SYNTHON BV
5-AMINOLEVULINIC ACID HYDROCHLORIDE 30 MG/ML POWDER FOR ORAL SOLUTION AS
MEDAC GESELLSCHAFT FUR KLINISCHE MANUFACTURED IN DESSAU-ROSSLAU, GERMANY AND WEDEL, GERMANY FOR MEDAC
24562 II 12/27/2010 SPEZIALPRAPARATE MBH GESELLSCHAFT FUER KLINISCHE SPEZIALPRAEPARATE MBH
24564 II 1/19/2011 MACLEODS PHARMACEUTICALS LIMITED TELMISARTAN AS MANUFACTURED IN GUJARAT, INDIA
POLYVINYL CHLORIDE HOMOPOLYMER RESIN AS MANUFACTURED IN FREEPORT TX, ADDIS LA, AND
24565 III 1/25/2011 SHINTECH INC PLAQUEMINE LA FOR SHINTECH INC
A06 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SAITAMA, JAPAN FOR NIPRO PATCH
24566 IV 1/21/2011 NIPRO PATCH CO LTD CO LTD
24567 III 1/21/2011 POLYONE CORP EM1001977260 AS MANUFACTURED IN AVON LAKE, OH
24568 III 1/21/2011 POLYONE CORP EM1001977660 AS MANUFACTURED IN AVON LAKE, OH
24569 III 1/21/2011 POLYONE CORP EM1001977360 AS MANUFACTURED IN AVON LAKE, OH
24570 III 1/21/2011 POLYONE CORP EM1001978560 AS MANUFACTURED IN AVON LAKE, OH
24571 III 1/21/2011 POLYONE CORP EM1001978460 AS MANUFACTURED IN AVON LAKE, OH
24572 III 1/21/2011 POLYONE CORP EM1001977460 AS MANUFACTURED IN AVON LAKE, OH

24574 II 2/3/2011 ORCHID CHEMICALS AND PHARMACEUTICALS LTD PALIPERIDONE AS MANUFACTURED IN MAHARASHTRA, INDIA
24575 III 1/20/2011 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-BLUE PP5M176067-ZN AS MANUFACTURED IN MALMO, SWEDEN
MANTROCEL K-100M AS MANUFACTURED IN SHANDONG PROVINCE, P.R. CHINA FOR MANTROSE
24576 IV 1/20/2011 MANTROSE HAEUSER CO INC HAEUSER CO INC
24577 II 3/8/2011 JUBILANT LIFE SCIENCES LIMITED VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN MYSORE DIST., INDIA
24578 II 3/10/2011 NATCO PHARMA LTD SORAFENIB TOSYLATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24579 II 1/24/2011 MERCK AND CIE DOTAP CHLORIDE AS MANUFACTURED IN SCHAFFHAUSEN, SWITZERLAND
24580 II 1/12/2011 HENAN DONGTAI PHARM CO LTD DICLOFENAC SODIUM AS MANUFACTURED IN HENAN PROVINCE, CHINA
FDA DATA AND REFERENCE MATERIAL: HISTORICAL CONTROL FOR EPILEPSY MONOTHERAPY
24581 V 2/2/2011 FDA CDER DIV NEUROLOGY PRODUCTS CLINICAL TRIALS
SALMETEROL XINAFOATE AS MANUFACTURED IN MONTROSE, UK; JURONG, SINGAPORE; WARE,
24582 II 3/23/2011 GLAXOSMITHKLINE LLC UK; EVREUX, FRANCE FOR GLAXOSMITHKLINE LLC
24583 II 1/26/2011 TAIZHOU TAIFA PHARMACEUTICALS CO LTD MEGESTROL ACETATE AS MANUFACTURED IN ZHEJIANG, CHINA
24584 II 2/1/2011 PARABOLIC DRUGS LTD CEFUROXIME AXETIL (CRYSTALLINE) PROCESS-III AS MANUFACTURED IN PUNJAB, INDIA
24585 II 1/28/2011 SIFAVITOR SRL HALOPERIDOL AS MANUFACTURED IN LODI, ITALY
24586 II 2/15/2011 IND SWIFT LABORATORIES LTD CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN PUNJAB, INDIA
24587 II 3/1/2011 SUN PHARMACEUTICAL INDUSTRIES LTD SEVELAMER CARBONATE AS MANUFACTURED IN GUJARAT, INDIA
24588 II 3/23/2011 SUN PHARMACEUTICAL INDUSTRIES LTD MONTELUKAST SODIUM AS MANUFACTURED IN GUJARAT, INDIA
 Page 5

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
RALOXIFENE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA FOR APOTEX
24589 II 2/1/2011 APOTEX PHARMACHEM INC PHARMACHEM INC
24590 II 1/31/2011 PHARMACEUTICAL WORKS POLPHARMA SA TADALAFIL AS MANUFACTURED IN GDANSKI, POLAND
24591 II 1/31/2011 ALCHYMARS ICM SM PRIVATE LTD RISEDRONATE SODIUM USP AS MANUFACTURED IN TAMILNADU, INDIA
MEGESTROL ACETATE USP (NON-STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN
24592 II 1/31/2011 ZHEJIANG XIANJU PHARMACEUTICAL CO LTD ZHEJIANG, CHINA
24593 II 2/1/2011 PARABOLIC DRUGS LTD CEFUROXIME ACID (PROCESS-III) AS MANUFACTURED IN PUNJAB, INDIA
24594 II 1/24/2011 AREVIPHARMA GMBH BUPRENORPHINE HYDROCHLORIDE AS MANUFACTURED IN RADEBEUL, GERMANY
HEBEI CHANGSHAN BIOCHEMICAL
24595 II 1/21/2011 PHARMACEUTICAL CO LTD HEPARIN SODIUM AS MANUFACTURED IN HEBEI PROVINCE, PEOPLE'S REPUBLIC OF CHINA
24597 II 3/5/2011 IND SWIFT LABORATORIES LTD FEXOFENADINE HYDROCHLORIDE USP AS MANUFACTURED IN PUNJAB, INDIA
24598 II 1/21/2011 SIFAVITOR SRL CLODRONATE DISODIUM TETRAHYDRATE AS MANUFACTURED IN LODI, ITALY
24599 II 2/1/2011 DR REDDYS LABORATORIES LIMITED LACOSAMIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24600 II 1/28/2011 DR REDDYS LABORATORIES LIMITED PALIPERIDONE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
ENTECAVIR HYDRATE, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN CHONGQING,
24601 II 1/28/2011 CHONGQING CARELIFE PHARMACEUTICAL CO LTD PEOPLE'S REPUBLIC OF CHINA
THERMOPLASTIC RESIN BROWN COLORANT MASTERBATCHES N08554-1, N08554-2, AND N08554-3
24602 III 1/13/2011 COLORS FOR PLASTICS INC AS MANUFACTURED IN ELK GROVE VILLAGE, IL AND SPARTANBURG, SC
24603 II 1/31/2011 RAKSHIT DRUGS PVT LTD PANTOPRAZOLE SODIUM USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24604 II 1/17/2011 SHANDONG KEYUAN PHARMACEUTICAL CO LTD METFORMIN HYDROCHLORIDE AS MANUFACTURED IN SHANDONG PROVINCE, CHINA
ULTRADUR® B4520 PRO UNCOLORED AS MANUFACTURED IN SCHWARZHEIDE, FEDERAL REPUBLIC
24605 III 1/21/2011 BASF SE OF GERMANY FOR BASF SE
ULTRAFORM® H4320 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL
24606 III 1/21/2011 BASF SE REPUBLIC OF GERMANY
ULTRAFORM® N2320 003 PRO UNCOLORED AS MANUFACTURED IN LUDWIGSHAFEN, FEDERAL
24607 III 1/21/2011 BASF SE REPUBLIC OF GERMANY
24608 II 2/3/2011 HETERO LABS LTD ZIDOVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24609 II 2/3/2011 HETERO LABS LTD LAMIVUDINE (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24610 II 2/3/2011 HETERO LABS LTD NEVIRAPINE ANHYDROUS AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24611 II 2/3/2011 SYMBIOTEC PHARMALAB LTD METHYLPREDNISOLONE ACETATE USP AS MANUFACTURED IN INDORE (M.P), INDIA
24614 II 2/4/2011 CENTER MOLECULAR RESEARCH LLC OXYGEN-18 ENRICHED WATER AS MANUFACTURED IN MOSCOW, RUSSIA
111717-B WHITE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA; CARTERSVILLE,
24616 III 1/28/2011 AMPACET CORP GA; AND HEATH, OH
24617 IV 1/28/2011 ABELEI INC 174A91 NATURAL & ARTIFICIAL COOL MINT FLAVOR AS MANUFACTURED IN NORTH AURORA, IL
163814 SPRING WATER BLUE PE MB AS MANUFACTURED IN TERRE HAUTE, IN; DERIDDER, LA;
24618 III 2/3/2011 AMPACET CORP CARTERSVILLE, GA; AND HEATH, OH

24620 IV 9/8/2010 TAKASAGO INTERNATIONAL CORP TAK-093146 MICRON® ARTIFICIAL STRAWBERRY FLAVOR AS MANUFACTURED IN TETERBORO, NJ
ACITRETIN AS MANUFACTURED IN SHAANXI PROVINCE, CHINA FOR CHONGQING HUAPONT
24621 II 2/8/2011 CHONGQING HUAPONT PHARMACEUTICAL CO LTD PHARMACEUTICAL CO LTD

24622 III 2/4/2011 BESPAK DIV CONSORT MEDICAL PLC BESPAK BK357 & BK361 SHARED VALVE INFORMATION AS MANUFACTURED IN NORFOLK, ENGLAND
 Page 6

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
TTS BACKING FILM M-PETP 12/ION 12/LDPE 40 (SPECIFICATION #178 INCLUDING #SOP13209 AND
24623 III 2/3/2011 AMCOR FLEXIBLES BURGDORF GMBH #SOP79007) AS MANUFACTURED IN BURGDORF, SWITZERLAND
OLOPATADINE HYDROCHLORIDE [ROUTE CODE - "OH"] AS MANUFACTURED IN ANDHRA PRADESH,
24624 II 2/8/2011 MSN LABORATORIES LTD INDIA
24625 II 3/18/2011 LUPIN LTD CLOPIDOGREL BISULFATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24626 II 2/11/2011 DERIVADOS QUIMICOS SA FINE CHEMICALS CICLETANINE HYDROCHLORIDE AS MANUFACTURED IN MURCIA, SPAIN
24627 II 1/31/2011 NECTAR LIFESCIENCES LTD CEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA

24628 II 1/30/2011 QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD MIFEPRISTONE AS MANUFACTURED IN HEBEI PROVINCE, CHINA
24629 II 2/11/2011 HETERO DRUGS LTD RITONAVIR USP (FORM I), PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24630 II 2/11/2011 SYMBIOTEC PHARMALAB LTD PREDNISOLONE HEMISUCCINATE USP AS MANUFACTURED IN INDORE (M.P), INDIA
24631 II 2/4/2011 SYN TECH CHEM AND PHARM CO LTD METAXALONE AS MANUFACTURED IN HSIN-YING, TAIWAN R.O.C.
24632 II 2/14/2011 ELAN DRUG DELIVERY INC N1714 TABLETS AS MANUFACTURED IN KING OF PRUSSIA, PA
NALOXONE HYDROCHLORIDE DRUG SUBSTANCE AS MANUFACTURED IN SCHAFFHAUSEN,
24633 II 2/15/2011 CILAG AG SWITZERLAND AND MOLINAZZO DI MONTEGGIO, SWITZERLAND FOR CILAG AG
24634 IV 2/12/2011 FLAMEL TECHNOLOGIES MEDUSA® PGLUVE TYPE POLYMER AS MANUFACTURED IN PESSAC, FRANCE
24635 III 2/7/2011 SRC MEDICAL INC VAGINAL APPLICATORS AS MANUFACTURED IN HANOVER, MA
24636 II 2/7/2011 SMRUTHI ORGANICS LTD CIPROFLOXACIN HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24637 III 2/16/2011 MITSUI CHEMICALS AMERICA INC ADMER SE800 AS MANUFACTURED IN CHIBA, JAPAN FOR MITSUI CHEMICALS AMERICA INC
TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE AS MANUFACTURED IN
24639 II 3/11/2011 ARCH PHARMALABS LTD MAHARASHTRA, INDIA
24640 II 2/16/2011 DR REDDYS LABORATORIES LIMITED OMEPRAZOLE [PROCESS-II] AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24641 II 2/16/2011 HETERO DRUGS LTD ESOMEPRAZOLE SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24642 II 2/15/2011 HOVIONE FARMACIENCIA SA SUMATRIPTAN USP AS MANUFACTURED IN LOURES, PORTUGAL
24644 II 2/16/2011 CADILA HEALTHCARE LIMITED OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA
JINAN JINDA PHARMACEUTICAL CHEMISTRY CO
24645 II 2/15/2011 LTD NITROFURANTOIN MACROCRYSTALS AS MANUFACTURED IN SHANDONG, CHINA
24647 II 2/18/2011 STERLING SRL FLUTICASONE FUROATE AS MANUFACTURED IN PERUGIA, ITALY
24648 III 2/18/2011 IDEMITSU UNITECH CO LTD PLALOC M-700 AS MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN
24649 II 2/14/2011 INKE SA ZOLMITRIPTAN AS MANUFACTURED IN BARCELONA, SPAIN
24650 II 1/24/2011 ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD RAMIPRIL AS MANUFACTURED IN ZHEJIANG, CHINA
24651 II 2/18/2011 STERLING SRL ETONOGESTREL AS MANUFACTURED IN PERUGIA, ITALY
24652 II 2/18/2011 EURAND INC EUR-1098 AS MANUFACTURED IN VANDALIA, OHIO

24653 II 1/27/2011 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD IRINOTECAN HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24655 II 2/21/2011 EMCURE PHARMACEUTICALS LTD ESZOPICLONE AS MANUFACTURED IN MAHARASHTRA, INDIA
24656 II 2/21/2011 DR REDDYS LABORATORIES LIMITED ABACAVIR SULPHATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24657 II 2/18/2011 YUNG ZIP CHEMICAL IND CO LTD METOPROLOL SUCCINATE AS MANUFACTURED IN TAIWAN, R.O.C.
HEAT ACTIVATED AND ADHESIVE APPLIED PACKAGING MATERIALS AS MANUFACTURED IN ESTADO
24658 III 2/18/2011 LAMINADOS FACARLYTE SA DE CV DE MEXICO, MEXICO
24659 II 2/18/2011 ESTEVE QUIMICA SA DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN TARRAGONA, SPAIN
 Page 7

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
ZHEJIANG MEDICINE CO LTD XINCHANG
24660 II 2/21/2011 PHARMACEUTICAL FACTORY LEVOFLOXACIN DS AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
PALONOSETRON HYDROCHLORIDE (NON STERILE API) AS MANUFACTURED IN SHANDONG
24661 II 2/19/2011 QILU PHARMACEUTICAL CO LTD PROVINCE, PEOPLE'S REPUBLIC OF CHINA
TAZOBACTAM SODIUM (STERILE API) AS MANUFACTURED IN SHANDONG PROVINCE, PEOPLE'S
24662 II 1/29/2011 QILU PHARMACEUTICAL CO LTD REPUBLIC OF CHINA
24665 II 2/23/2011 HETERO LABS LTD IRBESARTAN (FORM A) PROCESS II AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24666 II 2/23/2011 HETERO LABS LTD ZOLEDRONIC ACID MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24667 II 2/23/2011 HETERO DRUGS LTD MONTELUKAST SODIUM AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24669 II 2/25/2011 SMS PHARMACEUTICALS LTD ERLOTINIB HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24671 II 2/25/2011 ALEMBIC LTD API DIV OLMESARTAN MEDOXOMIL AS MANUFACTURED IN GUJARAT, INDIA
24672 V 2/24/2011 BD DIAGNOSTIC SYSTEMS MICROPRO MICROBIAL DETECTION SYSTEM
MEDICAL BACKING MATERIALS OF FILM LAMINATED NON-WOVEN AS MANUFACTURED IN SHIGA,
24673 III 2/18/2011 JAPAN VILENE CO LTD JAPAN
24675 II 2/15/2011 PHYTON BIOTECH LLC DOCETAXEL ANHYDROUS AS MANUFACTURED IN VANCOUVER, CANADA
APTAR UNITDOSE POWDER AND BIDOSE POWDER SYSTEMS AS MANUFACTURED IN CONGERS, NY
24676 III 2/14/2011 VALOIS SAS AND EIGELTINGEN, GERMANY FOR VALOIS SAS
24677 IV 3/11/2011 AUTHENTIX INC AUTHENTIX SECURITY MARKER AS MANUFACTURED IN ADDISON, TX
24678 II 2/22/2011 PARABOLIC DRUGS LTD OXACILLIN SODIUM USP AS MANUFACTURED IN HARYANA, INDIA
24679 II 2/25/2011 PARABOLIC DRUGS LTD CEPHALOTHIN SODIUM (STERILE) BUFFERED (USP) AS MANUFACTURED IN PUNJAB, INDIA
MIPRI AS MANUFACTURED IN ARAMON, FRANCE AND VILLENEUVE-LA-GARENNE, FRANCE FOR
24680 II 2/23/2011 PCAS PCAS
24681 II 2/25/2011 EMCURE PHARMACEUTICALS LTD FELODIPINE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24682 IV 2/25/2011 PHOSPHOLIPID GMBH PHOSAL® 53 MCT AS MANUFACTURED IN COLOGNE, GERMANY
24683 III 2/28/2011 ESSEL PROPACK LTD PLASTIC CAPS AND CLOSURES AS MANUFACTURED IN MAHARASHTRA, INDIA
24684 II 11/30/2010 MICRO LABS LTD ESCITALOPRAM OXALATE AS MANUFACTURED IN KARNATAKA, INDIA
24685 II 3/17/2011 ALKEM LABORATORIES LIMITED DULOXETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
24686 II 11/26/2010 MICRO LABS LTD CELECOXIB AS MANUFACTURED IN KARNATAKA, INDIA
24687 II 11/26/2010 MICRO LABS LTD TORSEMIDE USP AS MANUFACTURED IN KARNATAKA, INDIA
24688 II 11/26/2010 MICRO LABS LTD LOSARTAN POTASSIUM USP AS MANUFACTURED IN KARNATAKA, INDIA
24689 II 3/24/2011 SHILPA MEDICARE LTD CAPECITABINE USP AS MANUFACTURED IN KARNATAKA, INDIA
24691 II 3/2/2011 SYMBIOTEC PHARMALAB LTD DEFLAZACORT MICRONIZED AS MANUFACTURED IN INDORE (M.P.), INDIA
MANUFACTURE AND QUALITY CONTROL OF THE BC8-DOTA MONOCLONAL ANTIBODY CONJUGATE
24692 II 3/1/2011 FRED HUTCHINSON CANCER RESCTR (BC8-DOTA) AS MANUFACTURED IN SEATTLE, WA
24693 II 2/28/2011 ESTEVE QUIMICA SA RILUZOLE AS MANUFACTURED IN TARRAGONA, SPAIN

24694 II 2/25/2011 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD VALACYCLOVIR HYDROCHLORIDE AS MANUFACTURED IN ZHEJIANG PROVINCE, P.R. CHINA
24695 IV 2/24/2011 HENRY H OTTENS MANUFACTURING CO INC SPRAY DRIED ARTIFICIAL CARAMEL FLAVOR # S-989 AS MANUFACTURED IN PHILADELPHIA, PA
24696 III 2/28/2011 ESSEL PROPACK LTD UNPRINTED AND PRINTED LAMINATES AS MANUFACTURED IN MAHARASHTRA, INDIA
24698 II 3/2/2011 DR REDDYS LABORATORIES LIMITED PALIPERIDONE PALMITATE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
 Page 8

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
PACKAGING MATERIAL FOR 32 MM COMBINATED ALUMINIUM CAP AS MANUFACTURED IN LAILLY EN
24699 III 1/17/2011 EMA PHARMACEUTICALS VAL, FRANCE
24700 II 3/3/2011 SRINI PHARMACEUTICALS LTD PREGABALIN AS MANUFACTURED IN CHOUTUPPAL AP, INDIA
24701 II 3/1/2011 WANBURY LTD PENICILLAMINE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
OPHTHALMIC DRUG DELIVERY SYSTEMS AS MANUFACTURED IN RADOLFZELL, GERMANY AND
24704 III 3/3/2011 ING ERICH PFEIFFER GMBH EIGELTINGEN, GERMANY
24706 II 2/28/2011 TOMITA PHARMACEUTICAL CO LTD USP CALCIUM CHLORIDE DIHYDRATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
24707 II 12/20/2010 TOMITA PHARMACEUTICAL CO LTD USP ZINC GLUCONATE AS MANUFACTURED IN TOKUSHIMA, JAPAN
USP CALCIUM GLUCONATE, MONOHYDRATE (ORAL DOSAGE FORM) AS MANUFACTURED IN
24708 II 12/20/2010 TOMITA PHARMACEUTICAL CO LTD TOKUSHIMA, JAPAN
CLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM AS MANUFACTURED IN HUBEI
24709 II 2/20/2011 HEC PHARM CO LTD PROVINCE, P.R. CHINA
24710 IV 3/4/2011 FINAR CHEMICALS LTD TERTIARY BUTANOL HIGH PURITY GRADE (HP) AS MANUFACTURED IN GUJARAT, INDIA

24711 IV 3/7/2011 DAVID MICHAEL AND CO INC MICHAELOK® ARTIFICIAL STRAWBERRY FLAVOR #3095 AS MANUFACTURED IN PHILADELPHIA, PA
24712 II 3/9/2011 ALEMBIC LTD API DIV WARFARIN SODIUM AMORPHOUS USP AS MANUFACTURED IN GUJARAT, INDIA
NORTH CHINA PHARMACEUTICAL GROUP
24713 II 1/20/2011 SEMISYNTECH CO LTD AMPICILLIN TRIHYDRATE (NON STERILE, API) AS MANUFACTURED IN HEBEI, P.R. CHINA
24714 II 3/9/2011 ALEMBIC LTD API DIV MEXILETINE HYDROCHLORIDE AS MANUFACTURED IN GUJARAT, INDIA
HANGZHOU ZHONGMEI HUADONG
24716 II 3/8/2011 PHARMACEUTICAL CO LTD MUPIROCIN CALCIUM AS MANUFACTURED IN HANGZHOU, CHINA
24718 II 3/21/2011 JUBILANT LIFE SCIENCES LIMITED FAMPRIDINE AS MANUFACTURED IN MYSORE DIST., INDIA
24719 II 3/26/2011 JUBILANT LIFE SCIENCES LIMITED CYCLOBENZAPRINE HYDROCHLORIDE AS MANUFACTURED IN MYSORE DIST., INDIA
24720 II 3/25/2011 TORRENT PHARMACEUTICALS LTD TELMISARTAN USP AS MANUFACTURED IN GUJARAT, INDIA
24722 II 3/8/2011 ALCHYMARS ICM SM PRIVATE LTD MAFENIDE ACETATE USP AS MANUFACTURED IN TAMILNADU, INDIA
DAPTOMYCIN AS MANUFACTURED IN ZHEJIANG PROVINCE, PEOPLE'S REPUBLIC OF CHINA FOR
24723 II 3/4/2011 ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. ZHEJIANG HISUN PHARMACEUTICAL CO., LTD.
VALSARTAN AS MANUFACTURED IN UTTAR PRADESH, INDIA AND MADHYA PRADESH, INDIA FOR
24724 II 1/18/2011 TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD.
BA058-SOLID MICROSTRUCTURED TRANSDERMAL SYSTEM (BA058-SMTS) COATING AND DRYING
24727 II 3/10/2011 3M DRUG DELIVERY SYSTEMS PROCESS FOR THE FINISHED DRUG PRODUCT AS MANUFACTURED IN ST. PAUL, MN
24728 II 2/28/2011 FIS FABBRICA ITALIANA SINTETICI SPA CLOBAZAM AS MANUFACTURED IN VICENZA, ITALY
20.4566.CP PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24729 IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
58.3964.2P PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24730 IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY

24731 IV 12/10/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA 20.4554.CP PHA MILK FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY
58.3514.2P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24732 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
20.4582.2P PHA SOUR CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24733 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
 Page 9

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
20.4568.1G PHA STRAWBERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24734 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
58.4262.2L PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24735 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
20.4570.3P PHA PASSION FRUIT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24736 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
20.4564.2P PHA GRAPE FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24737 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
58.3748.UW PHA PEPPERMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24738 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
20.4563.UL PHA CHERRY FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24739 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
20.4557.1G PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24740 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
58.3754.1P PHA SPEARMINT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24741 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
20.4561.1P PHA BLACKCURRANT FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24742 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY

24743 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA 58.3536.1P PHA LIME FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO), ITALY
20.4579.1P PHA MIXED BERRIES FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO
24744 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA (TO), ITALY
58.3520.1P PHA LEMON FLAVOUR AS MANUFACTURED IN MOZZO (BG), ITALY AND TORINO (TO),
24745 IV 12/15/2010 KERRY INGREDIENTS AND FLAVOURS ITALIA SPA ITALY
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3] AS MANUFACTURED IN ANDHRA
24746 II 3/11/2011 DR REDDYS LABORATORIES LIMITED PRADESH, INDIA
24747 II 3/10/2011 SINTENOVO SA DE CV MONTELUKAST SODIUM AS MANUFACTURED IN MORELOS, MEXICO
24748 II 3/10/2011 NECTAR LIFESCIENCES LTD CEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE AS MANUFACTURED IN PUNJAB, INDIA
24749 II 3/10/2011 HENAN LIHUA PHARMACEUTICAL CO LTD PREDNISONE AS MANUFACTURED IN HENAN, CHINA
24750 II 3/14/2011 INDUSTRIALE CHIMICA SRL BUMETANIDE AS MANUFACTURED IN SARONNO (VARESSE), ITALY
SODIUM HYALURONATE FH AND SODIUM HYALURONATE FL AS MANUFACTURED IN TOCHIGI-PREF,
24751 II 3/10/2011 MARUHA NICHIRO FOODS INC JAPAN
ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO
24752 II 3/8/2011 LTD IRBESARTAN API AS MANUFACTURED IN ZHEJIANG PROVINCE, CHINA
24753 II 2/28/2011 MICRO LABS LTD DORZOLAMIDE HYDROCHLORIDE USP AS MANUFACTURED IN KARNATAKA, INDIA
24754 II 2/1/2011 ALEMBIC LTD API DIV AZITHROMYCIN MONOHYDRATE USP (PROCESS-II) AS MANUFACTURED IN GUJARAT, INDIA
24755 II 3/10/2011 CHANGZHOU PHARMACEUTICAL FACTORY ALISKIREN HEMIFUMARATE AS MANUFACTURED IN JIANGSU PROVINCE, CHINA
24757 II 3/15/2011 SRINI PHARMACEUTICALS LTD LEVETIRACETAM USP AS MANUFACTURED IN HYDERABAD AP, INDIA
24759 IV 3/14/2011 HENKEL CORP DURO-TAK 87-6911 PRESSURE SENSITIVE ADHESIVE AS MANUFACTURED IN SALISBURY, NC
24760 II 3/16/2011 DSM FINE CHEMICALS AUSTRIA NEOSTIGMINE METHYLSULFATE AS MANUFACTURED IN LINZ, AUSTRIA
24761 II 3/7/2011 DISHMAN PHARMACEUTICALS CHEMICALS LTD QUETIAPINE FUMARATE AS MANUFACTURED IN GUJARAT, INDIA
24762 II 3/15/2011 AARTI INDUSTRIES LTD DIFLUNISAL AS MANUFACTURED IN MAHARASHTRA, INDIA
 Page 10

1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
24763 II 3/15/2011 AIR LIQUIDE ELECTRONICS US LP NITRIC OXIDE AS MANUFACTURED IN MORRISVILLE, PA
24764 II 3/15/2011 MACLEODS PHARMACEUTICALS LIMITED TENOFOVIR DISOPROXIL FUMARATE AS MANUFACTURED IN GUJARAT, INDIA
24770 II 3/17/2011 HETERO LABS LTD CANDESARTAN CILEXETIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA
24771 III 3/10/2011 AVI GLOBAL PLAST PVT LTD CALENDARED RIGID PVC FILM FOR BLISTER PACKAGING AS MANUFACTURED IN DAMAN, INDIA

CASSETTE FOR PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB MXFDG

24772 V 1/31/2011 ROTEM INDUSTRIES LTD SYNTHESIS UNIT AS MANUFACTURED BY ROTEM INDUSTRIES LTD. IN MISHOR YAMIN, ISRAEL
24773 III 3/10/2011 FUTURISTIC PACKAGING PRIVATE LTD ALUMINIUM BLISTER FOIL (COATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA
24774 III 3/10/2011 FUTURISTIC PACKAGING PRIVATE LTD ALUMINIUM STRIP FOIL (LAMINATED/PRINTED) AS MANUFACTURED IN GUJARAT, INDIA
24775 II 3/16/2011 SMRUTHI ORGANICS LTD CIPROFLOXACIN USP AS MANUFACTURED IN MAHARASHTRA, INDIA
NEX 1506 MONOLAYER POLYETHYLENE SHEETING FILM AS MANUFACTURED IN TURNERS FALLS,
24776 III 3/8/2011 NEX PERFORMANCE FILMS MA AND MILTON, WI
24777 II 3/19/2011 EMCURE PHARMACEUTICALS LTD THIAMINE HYDROCHLORIDE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24778 II 3/22/2011 HETERO DRUGS LTD MEMANTINE HYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA
VINYL ACETATE/VINYL CHLORIDE CO-POLYMER FORMULATIONS AS MANUFACTURED IN ELK GROVE
24779 III 3/22/2011 DOW CHEMICAL CO VILLAGE, IL
CHOLESTEROL HP AS MANUFACTURED IN HYOGO, JAPAN AND SHIZUOKA, JAPAN FOR NIPPON FINE
24780 IV 3/18/2011 NIPPON FINE CHEMICAL CO LTD CHEMICAL CO LTD
ERGOTAMINE TARTRATE AS MANUFACTURED IN KOMAROV, CZECH REPUBLIC FOR TEVA
24782 II 3/23/2011 TEVA PHARMACEUTICALS INDUSTRIES LTD PHARMACEUTICAL INDUSTRIES LTD
24783 III 3/22/2011 TOYO INK MFG CO LTD ELBIMA Z117 AS MANUFACTURED IN TOKYO, JAPAN
24784 II 3/23/2011 EMCURE PHARMACEUTICALS LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA, INDIA
207420 STRAWBERRY FLAVOR #68998 AS MANUFACTURED IN HOLZMINDEN
GERMANY
24785 IV 1/6/2011 SYMRISE AG
24786 III 3/17/2011 ALPHAPET INC PREFORMANCE® PET 1708CC(A) AS MANUFACTURED IN DECATUR, AL
24787 II 3/22/2011 PARABOLIC DRUGS LTD CEFTAZIDIME FOR INJECTION (USP) AS MANUFACTURED IN PUNJAB, INDIA
24788 II 3/18/2011 FORMOSA LABORATORIES INC LAPATINIB DITOSYLATE AS MANUFACTURED IN TAOYUAN, TAIWAN
2-(2,3-DICHLOROPHENYL) METHYLENE HYDRAZINE CARBOXIMID AMIDINE AS MANUFACTURED IN
24789 II 3/22/2011 RA CHEM PHARMA LTD ANDHRA PRADESH, INDIA
24790 II 3/25/2011 ALEMBIC LTD API DIV LINEZOLID AS MANUFACTURED IN GUJARAT, INDIA
24791 II 3/25/2011 HOVIONE FARMACIENCIA SA FLUTICASONE PROPIONATE INHALATION GRADE AS MANUFACTURED IN LOURES, PORTUGAL
BECLOMETHASONE DIPROPIONATE HFA NASAL AEROSOL VALVE AS MANUFACTURED IN
24792 III 3/25/2011 3M DRUG DELIVERY SYSTEMS LANCASHIRE, GREAT BRITAIN FOR 3M DRUG DELIVERY SYSTEMS
24794 II 3/28/2011 EMCURE PHARMACEUTICALS LTD DOLASETRON MESYLATE USP AS MANUFACTURED IN MAHARASHTRA, INDIA
24795 II 3/24/2011 HENAN LIHUA PHARMACEUTICAL CO LTD PREDNISOLONE AS MANUFACTURED IN HENAN, CHINA
24796 II 3/29/2011 ALEMBIC LTD API DIV WARFARIN SODIUM CLATHRATE USP AS MANUFACTURED IN GUJARAT, INDIA
24797 II 3/29/2011 DIVIS LABORATORIES LTD VALSARTAN USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA

24798 II 3/23/2011 CHEMAGIS LTD PALONOSETRON HYDROCHLORIDE AS MANUFACTURED IN SHANGHAI, CHINA FOR CHEMAGIS LTD
24799 II 1/8/2011 SRI VYJAYANTHI LABS PVT LTD 2,3,4,5-BIS-O-(1-METHYLETHYLIDENE)-D-FRUCTOPYRANOSE AS MANUFACTURED IN A.P., INDIA
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1Q2011NEWEXCEL
DMF # SUBMIT DATE HOLDER SUBJECT
23612 II 3/30/2011 LUPIN LTD NORGESTREL USP AS MANUFACTURED IN MADHYA PRADESH, INDIA
24801 III 3/24/2011 CLARIANT MASTERBATCHES NORDEN AB MEVOPUR-PINK PE3M176130 AS MANUFACTURED IN MALMO, SWEDEN