2009年FDA首次批准的仿制药

2009年FDA首次批准的仿制药

2009年一月
First-TimeGenerics-January2009

GenericDrugNameGenericManufacturerBrandNameApprovalDate

1ALPRAZOLAMORALLYDISINTEGRATINGTABLETS,0.25MG,0.5MG,1MGAND2MG    KALILABORATORIES,INC.NIRAVAMORALLYDISINTEGRATINGTABLETS1/9/2009 
2LEVETIRACETAMORALSOLUTION,100MG/ML       ACTAVISMIDATLANTICLLCKEPPRAORALSOLUTION1/15/2009 
3LEVETIRACETAMORALSOLUTION,100MG/ML       AUROBINDOPHARMALTDKEPPRAORALSOLUTION,100MG/ML1/15/2009 
4LEVETIRACETAMORALSOLUTION,100MG/ML       TOLMARINC.KEPPRAORALSOLUTION1/15/2009 
5LEVETIRACETAMORALSOLUTION,100MG/ML       ROXANELABORATORIES,INC.KEPPRAORALSOLUTION1/15/2009 
6DIVALPROEXSODIUMDELAYEDRELEASECAPSULES(SPRINKLE),125MG(VALPROICACIDEQUIVALENT)       DR.REDDY"SLABORATORIES,INC.DEPAKOTESPRINKLECAPSULES,125MG1/23/2009 
7DIVALPROEXSODIUMEXTENDED-RELEASETABLETS,250MGAND500MG      MYLANPHARMACEUTICALS,INC.DEPAKOTEERTABLETS,250MGAND500MG1/29/2009 
8RISPERIDONEORALSOLUTION,1MG/ML       TEVAPHARMACEUTICALSUSARISPERDALORALSOLUTION1/30/2009 
9GALANTAMINEHYDROBROMIDEORALSOLUTION,4MG/ML       ROXANELABORATORIES,INC.RAZADYNEORALSOLUTION1/30/2009

2009年2月
First-TimeGenerics-February
2009 GenericDrugNameGenericManufacturerBrandNameApprovalDate

1MINOCYCLINEHYDROCHLORIDEEXTENDED-RELEASETABLETS,45MG(BASE),90MG(BASE)AND135MG(BASE)     IMPAXLABORATORIES,INC.SOLODYNTABLETS2/3/2009 
2SUMATRIPTANSUCCINATEINJECTION,4MG(BASE)/0.5MLAND6MG(BASE)/0.5ML;SINGLE-DOSEVIALS     SANDOZCANADA,INC.IMITREXINJECTION,SINGLEDOSEVIALS2/6/2009 
3SUMATRIPTANSUCCINATEINJECTION,6MG(BASE)/0.5ML;SINGLE-DOSEVIALS      BEDFORDLABORATORIESIMITREXINJECTION,6MG(BASE)/0.5ML2/6/2009 
4SUMATRIPTANSUCCINATEINJECTION,6MG(BASE)/0.5ML;SINGLE-DOSEVIALS      TEVAPARENTERALMEDICINESIMITREXINJECTION,6MG(BASE)/0.5ML2/6/2009 
5SUMATRIPTANSUCCINATEINJECTION(SYRINGE),4MG(BASE)/0.5MLAND6MG(BASE)/0.5ML;PRE-FILLEDSYRINGES     TEVAPARENTERALMEDICINESIMITREXINJECTION,8MG/ML,12MG/MLSYRINGE2/6/2009 
6SUMATRIPTANSUCCINATETABLETS,25MG(BASE),50MG(BASE)AND100MG(BASE)     TEVAPHARMACEUTICALSUSAIMITREXTABLETS2/9/2009 
7SUMATRIPTANSUCCINATETABLETS,100MG       RANBAXYLABORATORIESLIMITEDIMITREXTABLETS2/9/2009 
8RISPERIDONEORALLYDISINTEGRATINGTABLETS,0.5MGAND2MG      DR.REDDY"SLABORATORIESLIMITEDRISPERDALM-TAB(ORALLYDISINTEGRATINGTABLET2/24/2009 

2009年三月
First-TimeGenerics-March2009
GenericDrugNameGenericManufacturerBrandNameApprovalDate
1MALATHIONLOTION,USP0.5%      SYNERXPHARMA,LLCOVIDELOTION,0.5%3/6/2009 
2APRACLONIDINEOPHTHALMICSOLUTION,USP0.5%(BASE) AKORN,INC.IOPIDINEOPHTHALMICSOLUTION,0.5%3/12/2009
3LIOTHYRONINESODIUMTABLETS,USP5MCG,25MCG,AND50MCG COASTALPHARMACEUTICALSCYTOMELTABLETS3/20/2009
4LEVALBUTEROLINHALATIONSOLUTIONUSP,(CONCENTRATE)0.25%(1.25MG/0.5ML)      DEYLPXOPENEXINHALATIONSOLUTION(CONCENTRATE)3/20/2009
5IBUPROFENCAPSULES,200MG(LIQUIDFILLEDCAPSULE)(OTC)     BANNERPHARMACAPS,INC.ADVILLIQUI-GELSCAPSULES3/24/2009
6TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    TEVAPHARMACEUTICALSUSATOPAMAXTABLETS3/27/2009
7TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    ZYDUSPHARMACEUTICALSUSA,INC.TOPAMAXTABLETS3/27/2009
8TOPIRAMATETABLETS,25MG,50MGAND100MG     UNICHEMLABORATORIESLIMITEDTOPAMAXTABLETS3/27/2009
9TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    AUROBINDOPHARMALIMITEDTOPAMAXTABLETS3/27/2009
10TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG INVAGENPHARMACEUTICALS,INCTOPAMAXTABLETS3/27/2009
11TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    SUNPHARMACEUTICALINDUSTRIES,LTD.TOPAMAXTABLETS3/27/2009
12TOPIRAMATETABLETS,25MG,100MGAND200MGBARRLABORATORIES,INC.TOPAMAXTABLETS3/27/2009
13TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    ROXANELABORATORIES,INC.TOPAMAXTABLETS3/27/2009
14TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG GLENMARKGENERICSLIMITEDTOPAMAXTABLETS3/27/2009
15TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG   COBALTLABORATORIESTOPAMAXTABLETS3/27/2009
16TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    APOTEXINC.TOPAMAXTABLETS3/27/2009
17TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG   MYLANPHARMACEUTICALSINC.TOPAMAXTABLETS3/27/2009
18TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG    CIPLALIMITEDTOPAMAXTABLETS3/27/2009
19TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG   PARPHARMACEUTICAL,INCTOPAMAXTABLETS3/27/2009
20TOPIRAMATETABLETS,25MG,100MGAND200MG   RANBAXYLABLRATORIESLIMITEDTOPAMAXTABLETS3/27/2009
21TOPIRAMATETABLETS,25MG,50MG,100MGAND200MG   TORRENTPHARMACEUTICALSLIMITEDTOPAMAXTABLETS3/27/2009
22DROSPIRENONEANDETHINYLESTRADIOLTABLETS,3MG/0.02MG(28-DAYREGIMEN)     BARRLABORATORIES,INC.YAZTABLETS3/30/2009
23CARBAMAZEPINEEXTENDED-RELEASETABLETSUSP,100MG,200MGAND400MG  TAROPHARMACEUTICALSUSA,INC.TEGRETOL-XRTABLETS3/31/2009

2009年4月
First-TimeGenerics-April2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1TOPIRAMATECAPSULES(SPRINKLE),15MGAND25MG      BARRLABORATORIES,INC.TOPAMAXSPRINKLECAPSULES4/15/2009 
2TOPIRAMATECAPSULES(SPRINKLE),15MGAND25MG      COBALTLABORATORIES,INC.TOPAMAXSPRINKLECAPSULES4/15/2009 
3LORAZEPAMORALCONCENTRATE,USP2MG/ML       PADDOCKLABORATORIES,INC.INTENSOL4/28/2009 
4AZELASTINEHYDROCHLORIDENASALSOLUTION(NASALSPRAY),0.1%[125MCG(BASE)/SPRAY]       APOTEXINC.ASTELINNASALSPRAY4/30/2009 
5MIVACURIUMCHLORIDEINJECTION,2MG(BASE)/ML;PACKAGEDIN10MG(BASE)/5MLAND20MG(BASE)/10MLSINGLE-DOSEVIALS    EBEWEPARENTAPHARMACEUTICALS,INC.MIVACRONINJECTION4/30/2009 
6RISPERIDONEORALLYDISINTEGRATINGTABLETS,0.25MG,0.5MG,2MG,3MGAND4MG   KALILABORATORIES,INC.RISPERDAL-MTAB(ORALLYDISINTEGRATINGTABLET4/30/2009

2009年五月
First-TimeGenerics-May2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1TRIAMCINOLONEACETONIDEINJECTABLESUSPENSIONUSP,10MG/ML;PACKAGEDIN50MG/5MLMULTIPLE-DOSEVIALSSANDOZCANADA,INC.KENALOG-10INJECTABLESUSPENSION5/27/2009

2009年六月
First-TimeGenerics-June2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1TRIAMCINOLONEACETONIDEINJECTABLESUSPENSIONUSP,40MG/ML;PACKAGEDIN40MG/1MLVIALSAND200MG/5MLAND400MG/10MLMULTIPLE-DOSEVIALSSANDOZCANADAINC.KENALOG-40INJECTABLESUSPENSION6/1/2009
2OMEPRAZOLEMAGNESIUMDELAYED-RELEASECAPSULES,(OTC)20MG(BASE)DR.REDDY"SLABORATORIESLIMITEDPRILOSECOTCDELAYED-RELEASECAPSULES6/5/2009
3MELPHALANHYDROCHLORIDEFORINJECTION,50MG(BASE)/VIALSYNERXPHARMA,LLCALKERANFORINJECTION6/9/2009
4LEVONORGESTRELTABLETS(Rx)0.75MGWATSONLABORATORIES,INC.PLANB(LEVONORGESTREL)TABLETS,0.75MG6/24/2009
5OXCARBAZEPINEORALSUSPENSION,300MG/5MLRANBAXYLABORATORIESLIMITEDTRILEPTALORALSUSPENSION6/26/2009
6NORGESTIMATEANDETHINYLESTRADIOLTABLETSUSP,0.180MG/0.025MG;0.215MG/0.025MGAND0.250MG/0.025MG(28-DAYREGIMEN)BARRLABORATORIES,INC.ORTHOTRICYCLINLO6/29/2009

2009年七月
First-TimeGenerics-July2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1BICALUTAMIDETABLETSUSP,50MGMYLANPHARMACEUTICALS,INC.CASODEXTABLETS7/6/2009
2BICALUTAMIDETABLETSUSP,50MGACCORDHEALTHCAREINC.,USACASODEXTABLETS7/6/2009
3BICALUTAMIDETABLETSUSP,50MGSUNPHARMAGLOBAL,INC.CASODEXTABLETS7/6/2009
4BICALUTAMIDETABLETSUSP,50MGZYDUSPHARMACEUTICALSUSA,INC.CASODEXTABLETS7/6/2009
5BICALUTAMIDETABLETSUSP,50MGTEVAPHARMACEUTICALSUSACASODEXTABLETS7/6/2009
6BICALUTAMIDETABLETSUSP,50MGSANDOZINC.CASODEXTABLETS7/6/2009
7BICALUTAMIDETABLETSUSP,50MGSYNTHONPHARMACEUTICALS,INC.CASODEXTABLETS7/6/2009
8BICALUTAMIDETABLETSUSP,50MGKUDCOIRELAND,LTD.CASODEXTABLETS7/6/2009
9BENZTROPINEMESYLATEINJECTIONUSP,1MG/MLNEXUSPHARMACEUTICALSINC.COGENTININJECTION,1MG/ML7/28/2009
10TRIAMCINOLONEACETONIDENASALSPRAY0.055MG/SPRAYBARRLABORATORIES,INC.NASACORTAQNASALSPRAY,0.055MG/SPRAY7/30/2009
11BETAMETHASONEACETATE&BETAMETHASONESODIUMPHOSPHATEINJECTABLESUSPENSIONUSP,6MG/ML(3MG(BASE)/MLAND3MG/ML,RESPECTIVELY)PHARMAFORCE,INC.CELESTONESOLUSPANINJECTABLESUSPENSION7/31/2009

2009年八月
First-TimeGenerics-August2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1AZELASTINEHYDROCHLORIDEOPHTHALMICSOLUTION,0.05%APOTEXINC.OPTIVAROPHTHALMICSOLUTION8/3/2009
2OXALIPLATININJECTION,5MG/ML;(PRESERVATIVE-FREE),PACKAGEDIN50MG/10MLAND100MG/20MLSINGLE-USEVIALSHOSPIRAWORLDWIDEPTYELOXATININJECTION8/7/2009
3OXALIPLATINFORINJECTION,(PRESERVATIVE-FREE),PACKAGEDIN50MGAND100MGSINGLE-USEVIALSSUNPHARMAGLOBAL,FZEELOXATINFORINJECTION8/7/2009
4OXALIPLATINFORINJECTION,50MGAND100MG(PRESERVATIVE-FREE)SINGLE-USEVIALSFRESENIUSKABIONCOLOGY,PLCELOXATINFORINJECTION8/7/2009
5TACROLIMUSCAPSULES0.5MG,1MGAND5MGSANDOZ,INC.PROGRAFCAPSULES,0.5MG,1MGAND5MG8/10/2009
6CLINDAMYCINPHOSPHATEANDBENZOYLPEROXIDEGEL1%(BASE)/5%DOWPHARMACEUTICALSCIENCES,INC.BENZACLINTOPICALGEL8/11/2009
7ASPIRINANDDIPYRIDAMOLEEXTENDED-RELEASECAPSULES,25MG/200MGBARRLABORATORIES,INC.AGGRENOXEXTENDED-RELEASECAPSULES8/14/2009
8CLONIDINETRANSDERMALSYSTEM,USP0.1MG/DAY,0.2MG/DAYAND0.3MG/DAYAVEVADRUGDELIVERYSYSTEMS,INC.CATAPRES-TTS8/18/2009
9LEVONORGESTRELTABLETS,(RX/OTC)0.75MGWATSONLABORATORIES,INC.PLANBTABLETS8/28/2009

 
2009年9月
First-TimeGenerics-September2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1NORETHINDRONEACETATE&ETHINYLESTRADIOLTABLETSUSP,&FE1MG/0.02MGWITH75MGFERROUSFUMARATE(24-DAYREGIMEN)     WATSONLABORATOTRIES,INC.LOESTRIN24FETABLETS9/1/2009 
2TEMAZEPAMCAPSULESUSP,7.5MG       MUTUALPHARMACEUTICALCOMPANY,INC.RESTORILCAPSULES9/8/2009 
3NATEGLINIDETABLETS,60MGAND120MG      PARPHARMACEUTICAL,INC.STARLIXTABLETS9/9/2009 
4NATEGLINIDETABLETS,60MGAND120MG      DR.REDDY"SLABORATORIES,LIMITEDSTARLIXTABLETS9/9/2009 
5NATEGLINIDETABLETS,60MGAND120MG      TEVAPHARMACEUTICALSUSASTARLIXTABLETS9/9/2009 
6PIPERACILLINANDTAZOBACTAMFORINJECTION,36G(BASE)/4.5G(BASE)/VIAL,(PHARMACYBULKPACKAGE)      ORCHIDHEALTHCAREZOSYNFORINJECTION(PHARMACYBULKPACKAGE)9/15/2009 
7PIPERACILLINANDTAZOBACTAMFORINJECTION,2G(BASE)/250MG(BASE)/VIAL,3G(BASE)/375MG(BASE)/VIALAND4G(BASE)/500MG(BASE)/VIAL     ORCHIDHEALTHCAREZOSYNFORINJECTION9/15/2009 

First-TimeGenerics-October2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFUL  KREMERSURBANDEVELOPMENTCOMPANYMIRALAXFORORALSOLUTION10/6/2009
2POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULPERRIGOR&DCOMPANYMIRALAXPOWDERFORSOLUTION10/6/2009
3POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULNOVELLABORATORIES,INC.MIRALAXPOWDERFORSOLUTION10/6/2009
4POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULORSINGLE-DOSEPOUCH MYLANPHARMACEUTICALS,INC.MIRALAXPOWDERFORSOLUTION10/6/2009
5CLONIDINEHYDROCHLORIDEINJECTION,0.1MG/MLAND0.5MG/ML  PHARMAFORCE,INC.DURACLONINJECTION10/8/2009
6BUPRENORPHINEHYDROCHLORIDESUBLINGUALTABLETS,2MG(BASE)AND8MG(BASE)     ROXANELABORATORIES,INC.SUBUTEXSUBLINGUALTABLETS10/8/2009
7CHLOROTHIAZIDESODIUMFORINJECTIONUSP,500MG/VIALAPPPHARMACEUTICALS,INC.DIURILINJECTION,500MG/VIAL10/16/2009
8CHENODIOLTABLETS,250MG   NEXGENPHARMA,INC.CHENIXTABLETS,250MG10/22/2009
9ORALTRANSMUCOSALFENTANYLCITRATE,200MCG,400MCG,600MCG,800MCG,1200MCGAND1600MCH  BARRLABORATORIES,INC.ACTIQ10/30/2009
10ORALTRANSMUCOSALFENTANYLCITRATE,200MCG,400MCG,600MCG,800MCG,1200MCGAND1600MCG  MALLINCKRODTINC.ACTIQORALTRANSMUCOSALLOZENGE10/30/2009

First-TimeGenerics-October2009
GenericDrugNameGenericManufacturerBrandNameApprovalDate
1POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFUL  KREMERSURBANDEVELOPMENTCOMPANYMIRALAXFORORALSOLUTION10/6/2009
2POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULPERRIGOR&DCOMPANYMIRALAXPOWDERFORSOLUTION10/6/2009
3POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULNOVELLABORATORIES,INC.MIRALAXPOWDERFORSOLUTION10/6/2009
4POLYETHYLENEGLYCOL3350POWDERFORSOLUTION,(OTC),17GRAMS/SCOOPFULORSINGLE-DOSEPOUCH MYLANPHARMACEUTICALS,INC.MIRALAXPOWDERFORSOLUTION10/6/2009
5CLONIDINEHYDROCHLORIDEINJECTION,0.1MG/MLAND0.5MG/ML  PHARMAFORCE,INC.DURACLONINJECTION10/8/2009
6BUPRENORPHINEHYDROCHLORIDESUBLINGUALTABLETS,2MG(BASE)AND8MG(BASE)     ROXANELABORATORIES,INC.SUBUTEXSUBLINGUALTABLETS10/8/2009
7CHLOROTHIAZIDESODIUMFORINJECTIONUSP,500MG/VIALAPPPHARMACEUTICALS,INC.DIURILINJECTION,500MG/VIAL10/16/2009
8CHENODIOLTABLETS,250MG   NEXGENPHARMA,INC.CHENIXTABLETS,250MG10/22/2009
9ORALTRANSMUCOSALFENTANYLCITRATE,200MCG,400MCG,600MCG,800MCG,1200MCGAND1600MCH  BARRLABORATORIES,INC.ACTIQ10/30/2009
10ORALTRANSMUCOSALFENTANYLCITRATE,200MCG,400MCG,600MCG,800MCG,1200MCGAND1600MCG  MALLINCKRODTINC.ACTIQORALTRANSMUCOSALLOZENGE10/30/2009

2009年11月

First-TimeGenerics-November2009
 GenericDrugNameGenericManufacturerBrandNameApprovalDate
1KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.4% APOTEXINC.ACULARLSOPHTHALMICSOLUTION11/5/2009
2KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.5%ALCONINC.ACULAROPHTHALMICSOLUTION11/5/2009
3KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.4% ALCONINC.ACULARLSOPHTHALMICSOLUTION11/5/2009
4KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.5%AKORNINC.ACULAROPHTHALMICSOLUTION11/5/2009
5KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.4%AKORNINC.ACULARLSOPHTHALMICSOLUTION11/5/2009
6KETOROLACTROMETHAMINEOPHTHALMICSOLUTION,0.5% SUNPHARMAGLOBAL,INC.ACULAROPHTHALMICSOLUTION11/5/2009
7NORETHINDRONEACETATEANDETHINYLESTRADIOLTABLETSUSP,1MG/0.005MGBARRLABORATORIES,INC.FEMHRTTABLETS1MG/0.005MG11/6/2009
8LANSOPRAZOLEDELAYED-RELEASECAPSULESUSP,15MGAND30MGTEVAPHARMACEUTICALSUSAPREVACIDDELAYED-RELEASECAPSULES11/10/2009
9PERINDOPRILERBUMINETABLETS,2MG,4MGAND8MGAUROBINDOPHARMALIMITEDACEONTABLETS11/10/2009
10PERINDOPRILERBUMINETABLETS,2MG,4MGAND8MG  ROXANELABORATORIES,INC.ACEONTABLETS11/10/2009
11LANSOPRAZOLEDELAYED-RELEASECAPSULESUSP,15MGAND30MGMATRIXLABORATORIESLIMITEDPREVACIDDELAYED-RELEASECAPSULES11/10/2009
12PERINDOPRILERBUMINETABLETS,2MG,4MGAND8MGIVAXPHARMACEUTICALS,INC.ACEONTABLETS11/10/2009
13TRAMADOLHYDROCHLORIDEEXTENDED-RELEASETABLETS,100MGAND200MG    PARPHARMACEUTICAL,INC.ULTRAMERTABLETS,100MGAND200MG11/13/2009
14NICARDIPINEHYDROCHLORIDEINJECTION,2.5MG/ML;PACKAGEDIN25MG/10MLSINGLE-DISEVIALSGENERAMEDIX,INC.CARDENEI.V.INJECTION11/17/2009
15NICARDIPINEHYDROCHLORIDEINJECTION,2.5MG/ML;PACKAGEDIN25MG/10MLSINGLE-USEVIALS PHARMAFORCE,INC.CARDENEI.V.INJECTION11/17/2009
16NICARDIPINEHYDROCHLORIDEINJECTION,2.5MG/ML;PACKAGEDIN25MG/10MLSINGLE-USEVIALS NAVINTA,LLCCARDENEI.V.INJECTION11/17/2009
17NICARDIPINEHYDROCHLORIDEINJECTION,2.5MG/ML,PACKAGEDIN25MG/10MLSINGLE-USEAMPULSSUNPHARMAGLOBAL,INC.CARDENEI.V.INJECTION11/17/2009
18NICARDIPINEHYDROCHLORIDEINJECTION,2.5MG/ML;PACKAGEDIN25MG/10MLSINGLE-USEVIALS WOCKHARDTLIMITEDCARDENEI.V.INJECTION11/17/2009
19NIZATIDINEORALSOLUTION,15MG/ML    AMNEALPHARMACEUTICALSAXIDORALSOLUTION11/18/2009 

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