FDA08年批准的药品(片剂,注射剂,抗生素,胶囊,盐酸) - 生物药学 - 生物秀
标题: FDA08年批准的药品(片剂,注射剂,抗生素,胶囊,盐酸)
摘要: FDA08年一月批准的药品（上）申请号 活性成分 公司批准类型 批准日
剂型 适应症NDA
021924LEVOTHYROXINE SODIUM甲状腺素钠INST BIOCHIMIQUESupplement01 01 2008胶囊甲状腺功能不足病，垂腺TSH抑制NDA
018031HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE氢氯噻嗪 ……
FDA08年一月批准的药品（上）
申请号 活性成分 公司批准类型 批准日
剂型 适应症
NDA # 021924LEVOTHYROXINE SODIUM甲状腺素钠INST BIOCHIMIQUESupplement01/01/2008胶囊甲状腺功能不足病，垂腺TSH抑制
NDA # 018031HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE氢氯噻嗪/盐酸普萘洛尔WYETH PHARMS INCLabeling Revision01/02/2008片剂高血压
NDA # 020356NISOLDIPINE尼索地平SCIELE PHARMA INCFormulation Revision01/02/2008胶囊剂（ER）高血压
NDA # 021438PROPRANOLOL HYDROCHLORIDE盐酸普萘洛尔RELIANT PHARMSLabeling Revision01/02/2008片剂（ER）高血压
NDA # 022044METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE盐酸二甲双胍磷酸西他列汀MERCKLabeling Revision01/02/2008片剂2型糖尿病
NDA # 020375ESTRADIOL雌二醇BAYER HLTHCARELabeling Revision01/03/2008膜剂（ER）雌激素
NDA # 020522SOMATROPIN RECOMBINANT基因重组人生长激素GENENTECHManufacturing Change or Addition01/03/2008注射剂生长素
ANDA # 077963GRANISETRON HYDROCHLORIDE盐酸格拉司琼TEVA PARENTERALApproval01/03/2008注射剂化疗止吐
ANDA # 078596METFORMIN HYDROCHLORIDE盐酸二甲双胍INTERPHARMApproval01/03/2008片剂（ER）降糖药
ANDA # 077643TOPIRAMATE HYDROCHLORIDE盐酸托吡酯COBALTTentative Approval01/04/2008片剂抗癫痫(epilepsy)(epilepsy)药
ANDA # 078769IBUPROFEN; OXYCODONE HYDROCHLORIDE布洛芬盐酸羟考酮ACTAVIS ELIZABETHApproval01/04/2008片剂镇痛药
NDA # 050207ERYTHROMYCIN ETHYLSUCCINATE琥乙红霉素ABBOTTLabeling Revision01/05/2008颗粒剂抗生素(antibiotic)(antibiotic)
NDA # 050611ERYTHROMYCIN红霉素ABBOTTLabeling Revision01/05/2008片剂，包衣颗粒抗生素(antibiotic)(antibiotic)
NDA # 021368TADALAFIL他达那非LILLYNew Dosage Regimen01/07/2008片剂性勃起功能障碍
ANDA # 065434CEFDINIR头孢地尼AUROBINDO PHARMAApproval01/07/2008胶囊剂抗生素(antibiotic)(antibiotic)
ANDA # 077062FENTANYL芬太尼ABRIKA PHARMSControl Supplement01/07/2008膜剂（ER）镇痛药
ANDA # 078151TERBUTALINE SULFATE硫酸特布他林AKORNApproval01/07/2008注射剂平喘药
NDA # 017963METOPROLOL TARTRATE酒石酸美托洛尔NOVARTISLabeling Revision01/08/2008片剂高血压
NDA # 018303HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE氢氯噻嗪酒石酸美托洛尔NOVARTISLabeling Revision01/08/2008片剂高血压
NDA # 019649RIMANTADINE HYDROCHLORIDE盐酸金刚乙胺FOREST LABSLabeling Revision01/08/2008片剂抗病毒
ANDA # 077129RIVASTIGMINE TARTRATE酒石酸卡巴拉汀WATSON LABSApproval01/08/2008胶囊剂抗AD药
ANDA # 077297GRANISETRON HYDROCHLORIDE盐酸格拉司琼SICOR PHARMSTentative Approval01/08/2008注射剂化疗止吐
ANDA # 077917PRAVASTATIN SODIUM 普伐他汀钠LUPIN PHARMSApproval01/08/2008胶囊剂高脂血症
ANDA # 078090GRANISETRON HYDROCHLORIDE盐酸格拉司琼ABRAXIS PHARMTentative Approval01/08/2008注射剂化疗止吐
ANDA # 078403SERTRALINE HYDROCHLORIDE盐酸舍曲林WOCKHARDTApproval01/08/2008片剂抗抑郁药
NDA # 021490ETHINYL ESTRADIOL; NORETHINDRONE炔雌醇炔诺酮WARNER CHILCOTTLabeling Revision01/09/2008咀嚼片避孕药
ANDA # 040094ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚+重酒石酸可待因酮WATSON LABSSupplier Addition01/09/2008片剂镇痛药
ANDA # 077051FENTANYL芬太尼LAVIPHARM LABSControl Supplement01/09/2008膜剂（ER）镇痛药
ANDA # 076507FLUCONAZOLE氟康唑TAROControl Supplement01/09/2008片剂抗菌药
ANDA # 078339GEMCITABINE吉西他宾HOSPIRA INCTentative Approval01/09/2008注射剂抗肿瘤药
NDA # 021610OXYMORPHONE HYDROCHLORIDE盐酸羟吗啡酮ENDO PHARMSControl Supplement01/10/2008片剂（ER）镇痛药
NDA # 021658CICLESONIDE环索奈德NYCOMED US INCApproval01/10/2008吸入剂平喘药
ANDA # 065342CEFTRIAXONE头孢曲松HIKMA FARMACEUTICAApproval01/10/2008注射剂抗生素(antibiotic)(antibiotic)
ANDA # 065372POLYMYXIN B SULFATE硫酸多粘菌素BABRAXIS PHARM PRODSApproval01/10/2008注射剂多肽类抗生素(antibiotic)(antibiotic)
ANDA # 078213PROPRANOLOL HYDROCHLORIDE普萘洛尔NORTHSTAR HLTHCAREApproval01/10/2008片剂高血压
NDA # 021153ESOMEPRAZOLE MAGNESIUM埃索美拉唑镁ASTRAZENECALabeling Revision01/11/2008胶囊（DR）PPI
NDA # 021773EXENATIDE SYNTHETIC类高血糖因子AMYLINLabeling Revision01/11/2008注射剂降糖药
ANDA # 065305CEFTRIAXONE SODIUM头孢曲松钠LUITPOLDApproval01/11/2008注射剂抗生素(antibiotic)(antibiotic)
ANDA # 077344DONEPEZIL HYDROCHLORIDE盐酸多奈哌齐TEVA PHARMSTentative Approval01/11/2008片剂抗AD药
ANDA # 077620GLIPIZIDE; METFORMIN HYDROCHLORIDE吡嗪双胍片CARACOApproval01/11/2008片剂降糖药
ANDA # 077631CETIRIZINE HYDROCHLORIDE盐酸西替利嗪CARACOApproval01/11/2008片剂抗过敏药
ANDA # 078069OXCARBAZEPINE奥卡西平BRECKENRIDGE PHARMApproval01/11/2008片剂抗癫痫(epilepsy)(epilepsy)药
NDA # 020998CELECOXIB塞来昔布GD SEARLELabeling Revision01/14/2008胶囊剂关节炎
NDA # 021083SIROLIMUS西罗莫司WYETH PHARMS INCEfficacy Supplement with Clinical Data to Support01/14/2008口服溶液免疫抑制剂
ANDA # 076273CLOPIDOGREL BISULFATE氯吡格雷硫酸氢盐DR REDDYS LABS INCApproval01/14/2008片剂抗凝血药
ANDA # 078145KETOROLAC TROMETHAMINE酮咯酸氨丁三醇LUITPOLDApproval01/14/2008注射剂止痛药
ANDA # 078198GRANISETRON HYDROCHLORIDE盐酸格拉司琼APOTEXTentative Approval01/14/2008注射剂化疗止吐
BLA # 125104NATALIZUMAB那他珠单抗BIOGEN IDECSupplement01/14/2008注射剂抗肿瘤药
08年一月批准的药品（下）
NDA # 021350FENOFIBRATE非诺贝特SKYEPHARMA AGLabeling Revision01/15/2008片剂高脂血症
ANDA # 077793PRAVASTATIN SODIUM普伐他汀钠TEVA PHARMSApproval01/15/2008片剂高脂血症
ANDA # 078343CETIRIZINE HYDROCHLORIDE盐酸西替利嗪DR REDDYS LABS LTDApproval01/15/2008片剂抗过敏药
ANDA # 078662DONEPEZIL HYDROCHLORIDE盐酸多奈哌齐ROXANETentative Approval01/15/2008片剂抗AD药
NDA # 021071ROSIGLITAZONE MALEATE马来酸罗格列酮SB PHARMCOLabeling Revision01/16/2008片剂降糖药
NDA # 021426SOMATROPIN RECOMBINANT基因重组人生长激素SANDOZFormulation Revision01/16/2008注射剂生长素
ANDA # 077570FLUTICASONE PROPIONATE丙酸氟替卡松HI TECH PHARMAApproval01/16/2008气雾剂糖皮质激素
ANDA # 078143FLUOXETINE HYDROCHLORIDE盐酸氟西汀WOCKHARDTApproval01/16/2008胶囊剂抗抑郁药
ANDA # 078477AMLODIPINE BESYLATE苯磺酸氨氯地平INTERPHARMApproval01/16/2008片剂高血压
ANDA # 078598CIPROFLOXACIN HYDROCHLORIDE盐酸环丙沙星PHARMAFORCEApproval01/16/2008滴剂抗生素(antibiotic)(antibiotic)
NDA # 021087OSELTAMIVIR PHOSPHATE磷酸奥司他韦ROCHELabeling Revision01/17/2008混悬液抗病毒药
NDA # 021471AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE阿沃苯松/依莰舒/奥克立林/二氧化钛LOREAL USALabeling Revision01/17/2008乳膏防晒剂
NDA # 022067PREDNISOLONE ACETATE醋酸泼尼松龙TAROApproval01/17/2008混悬液糖皮质激素
ANDA # 076740NIMODIPINE尼莫地平BANNER PHARMACAPSApproval01/17/2008胶囊高血压
NDA # 019537CIPROFLOXACIN HYDROCHLORIDE盐酸环丙沙星BAYER PHARMSLabeling Revision01/18/2008片剂抗生素(antibiotic)(antibiotic)
NDA # 020780 CIPROFLOXACIN 环丙沙星BAYER PHARMSLabeling Revision01/18/2008混悬液抗生素(antibiotic)(antibiotic)
NDA # 021176COLESEVELAM HYDROCHLORIDE盐酸考来维仑DAIICHI SANKYONew or Modified Indication01/18/2008片剂降糖药
NDA # 021180ETHINYL ESTRADIOL; NORELGESTROMIN乙炔雌二醇/甲基孕酮ORTHO MCNEIL PHARMLabeling Revision01/18/2008膜剂（ER）避孕药
NDA # 021229OMEPRAZOLE MAGNESIUM奥美拉唑镁ASTRAZENECALabeling Revision01/18/2008片剂（ER）PPI
NDA # 021473CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE环丙沙星，盐酸环丙沙星BAYER PHARMSLabeling Revision01/18/2008片剂（ER）抗生素(antibiotic)(antibiotic)
NDA # 022107ALISKIREN HYDROCHLOROTHIAZIDE阿利吉仑/氢氯噻嗪NOVARTIS PHARMSApproval01/18/2008片剂高血压
NDA # 022187ETRAVIRINE伊他韦恩TIBOTECApproval01/18/2008片剂抗病毒药
ANDA # 077255LANSOPRAZOLE兰索拉唑TEVA PHARMSTentative Approval01/18/2008胶囊剂（DR）PPI
BLA # 103792TRASTUZUMAB曲妥珠单抗GENENTECHSupplement01/18/2008注射剂抗肿瘤药
BLA # 125057ADALIMUMAB阿达木单抗ABBOTTSupplement01/18/2008注射剂关节炎、银屑病等
NDA # 017628TOLMETIN SODIUM托尔米汀钠ORTHO MCNEIL PHARMLabeling Revision01/22/2008胶囊剂NSAID
NDA # 021506MICAFUNGIN SODIUM米卡芬净钠ASTELLASNew or Modified Indication01/22/2008注射剂抗菌药
NDA # 050580AZTREONAM氨曲南BRISTOL MYERS SQUIBBLabeling Revision01/22/2008注射剂抗生素(antibiotic)(antibiotic)
NDA # 021538SOMATROPIN rDNA ORIGINAL人生长激素原始rDNACANGENE CORPApproval01/23/2008注射剂生长素
NDA # 050813AMOXICILLIN阿莫西林MIDDLEBROOK PHARMAApproval01/23/2008片剂（ER）抗生素(antibiotic)(antibiotic)
ANDA # 077453OXYTOCIN缩宫素TEVA PARENTERALApproval01/24/2008注射剂引产、产后出血等
BLA # 103705RITUXIMAB利妥昔单抗GENENTECHSupplement01/24/2008注射剂抗肿瘤药
NDA # 018827BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE二丙酸倍他米松克霉唑SCHERINGLabeling Revision01/25/2008乳膏抗菌药
NDA # 020010BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE二丙酸倍他米松克霉唑SCHERING PLOUGH RESLabeling Revision01/25/2008洗液抗菌药
NDA # 021166ESTRADIOL雌二醇ASCENDLabeling Revision01/25/2008凝胶剂雌激素
NDA # 022023FOSAPREPITANT DIMEGLUMINE阿瑞吡坦二甲葡胺MERCK CO INCApproval01/25/2008粉末剂止吐药
ANDA # 040517METHADONE HYDROCHLORIDE盐酸美沙酮MALLINCKRODTControl Supplement01/26/2008片剂镇静剂
ANDA # 040545ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE对乙酰氨基酚/盐酸羟氢可待酮MALLINCKRODTControl Supplement01/26/2008片剂镇静剂
ANDA # 075618ACETAMINOPHEN/BUTALBITAL/CAFFEINE/CODEINE PHOSPHATE对乙酰氨基酚,布他比妥,咖啡因,磷酸可待因WEST WARDSupplier Addition01/26/2008胶囊剂镇静剂
ANDA # 087757ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚+重酒石酸可待因酮SCHWARZ PHARMAControl Supplement01/26/2008片剂镇痛药
NDA # 020639QUETIAPINE FUMARATE富马酸奎硫平ASTRAZENECALabeling Revision01/28/2008片剂精神分裂症
NDA # 022157LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪UCB INCApproval01/28/2008口服溶液抗过敏药
ANDA # 040762PHENDIMETRAZINE TARTRATE酒石酸苯甲曲秦AMIDE PHARMApproval01/28/2008片剂肥胖症
ANDA # 040874DIPYRIDAMOLE 双嘧达莫ZYDUS PHARMS USA INCApproval01/28/2008片剂抗血栓
ANDA # 065185BLEOMYCIN SULFATE硫酸博来霉素ABRAXIS PHARMApproval01/28/2008注射剂抗肿瘤抗生素(antibiotic)(antibiotic)
NDA # 021476ESZOPICLONE右佐匹克隆SEPRACORLabeling Revision01/29/2008片剂失眠
ANDA # 040776DEXTROAMPHETAMINE SULFATE右旋苯丙胺硫酸盐OUTLOOK PHARMSApproval01/29/2008口服溶液肥胖症
ANDA # 077630TAMSULOSIN HYDROCHLORIDE盐酸坦索罗辛TEVA PHARMSTentative Approval01/29/2008胶囊剂前列腺疾病
ANDA # 078066CALCITRIOL骨化三醇AKORNApproval01/29/2008注射剂维生素类药
ANDA # 078242TECHNETIUM TC-99M MEBROFENIN KIT锝99甲溴菲宁盒CISApproval01/29/2008——诊断用药
ANDA # 078850LAMIVUDINE拉米夫定INVAGEN PHARMSTentative Approval01/29/2008片剂乙肝
NDA # 020151VENLAFAXINE HYDROCHLORIDE盐酸维拉法辛WYETH PHARMS INCLabeling Revision01/30/2008片剂抗抑郁药
NDA # 020699VENLAFAXINE HYDROCHLORIDE盐酸维拉法辛WYETH PHARMS INCLabeling Revision01/30/2008胶囊剂（ER）抗抑郁药
ANDA # 040732PHENYTOIN SODIUM苯妥英钠WOCKHARDT USAApproval01/30/2008胶囊剂抗癫痫(epilepsy)(epilepsy)药
ANDA # 077693CALCIUM ACETATE醋酸钙ROXANEApproval01/30/2008片剂营养补充剂
ANDA # 078075BRIMONIDINE TARTRATE酒石酸溴莫尼定SANDOZApproval01/30/2008滴眼液青光眼
ANDA # 078327SUMATRIPTAN SUCCINATE舒马坦琥珀酸盐AUROBINDO PHARMATentative Approval01/30/2008片剂偏头痛
ANDA # 078725GRANISETRON HYDROCHLORIDE盐酸格拉司琼MYLANApproval01/30/2008注射剂抗肿瘤药
NDA # 020683ETHINYL ESTRADIOL; LEVONORGESTREL炔雌醇左炔诺孕酮WYETH PHARMS INCLabeling Revision01/31/2008片剂避孕药
NDA # 021437EPLERENONE依普利酮GD SEARLE LLCPatient Population Altered01/31/2008片剂高血压
NDA # 021928VARENICLINE TARTRATE酒石酸瓦伦尼克林PFIZER INCLabeling Revision01/31/2008片剂戒烟药
NDA # 022064LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪UCB INCLabeling Revision01/31/2008片剂抗过敏药
ANDA # 077260IRINOTECAN HYDROCHLORIDE盐酸伊立替康TEVA PARENTERALTentative Approval01/31/2008注射剂抗肿瘤药
ANDA # 077760PROPRANOLOL HYDROCHLORIDE盐酸普萘洛尔HIKMA FARMACEUTICAApproval01/31/2008注射剂高血压
ANDA # 078002CAFFEINE CITRATE柠檬酸咖啡因ABRAXIS PHARM PRODSApproval01/31/2008口服溶液兴奋剂
ANDA # 078081AMLODIPINE BESYLATE苯磺酸氨氯地平MUTUAL PHARMAApproval01/31/2008片剂高血压
ANDA # 078619FLUOXETINE HYDROCHLORIDE盐酸氟西汀AUROBINDO PHARMAApproval01/31/2008胶囊剂抗抑郁药
ANDA # 078626SERTRALINE HYDROCHLORIDE盐酸舍曲林MATRIX LABS LTDApproval01/31/2008片剂抗抑郁药
ANDA # 078787GABAPENTIN加巴喷丁AUROBINDO PHARMApproval01/31/2008胶囊剂抗癫痫(epilepsy)(epilepsy)药网友回复FDA08年二月批准的药品（上）
NDA # 020564LAMIVUDINE拉米夫定GLAXOSMITHKLINEPatient Population Altered02/01/2008片剂慢乙肝
NDA # 007638CHLORPHENIRAMINE MALEATE马来酸氯苯那敏SCHERING PLOUGHLabeling Revision02/04/2008片剂（ER）抗过敏药
NDA # 017058METHADONE HYDROCHLORIDE盐酸美沙酮ROXANELabeling Revision02/04/2008片剂戒毒药
NDA # 017116METHADONE HYDROCHLORIDE盐酸美沙酮MALLINCKRODTLabeling Revision02/04/2008浓缩液戒毒药
NDA # 018063NADOLOL纳多洛尔KING PHARMSLabeling Revision02/04/2008片剂高血压
NDA # 021272TREPROSTINIL SODIUM曲前列环素钠UNITED THERAPLabeling Revision02/04/2008注射剂肺动脉高压
ANDA # 078785ATAZANAVIR SULFATE阿扎那韦硫酸盐EMCURE PHARMATentative Approval02/04/2008胶囊剂抗病毒药
NDA # 021140LOPERAMIDE HYDROCHLORIDE; SIMETHICONE盐酸洛哌丁胺/二甲基硅油MCNEIL CONSLabeling Revision02/05/2008片剂止泻药
NDA # 021266VORICONAZOLE伏立康唑PFIZERLabeling Revision02/05/2008片剂抗菌药
NDA # 021514METHYLPHENIDATE哌甲酯SHIRELabeling Revision02/05/2008膜剂（ER）ADHD（多动）
NDA # 021730LEVALBUTEROL TARTRATE左旋沙丁胺醇酒石酸盐SEPRACORControl Supplement02/05/2008气雾剂支气管痉挛
NDA # 021881ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE抗坏血酸/聚乙二醇3350/氯化钾/VC钠/氯化钠/硫酸钠SALIX PHARMSLabeling Revision02/05/2008口服溶液清肠
ANDA # 065323CEFUROXIME AXETIL头孢呋辛酯RANBAXYApproval02/05/2008口服混悬剂抗生素(antibiotic)
ANDA # 077830ESOMEPRAZOLE MAGNESIUM埃索美拉唑镁RANBAXYTentative Approval02/05/2008胶囊（DR）PPI
NDA # 017577OXYBUTYNIN CHLORIDE盐酸奥昔布宁ALZALabeling Revision02/06/2008片剂膀胱炎、尿道炎
NDA # 020238CIMETIDINE甲腈咪胺GLAXOSMITHKLINELabeling Revision02/06/2008片剂抗胃溃疡药
NDA # 050006DOXYCYCLINE多西环素PFIZERLabeling Revision02/06/2008混悬剂抗生素(antibiotic)
NDA # 050007DOXYCYCLINE HYCLATE盐酸多西环素PFIZERLabeling Revision02/06/2008胶囊剂抗生素(antibiotic)
NDA # 050480DOXYCYCLINE CALCIUM多西环素钙PFIZERLabeling Revision02/06/2008混悬剂抗生素(antibiotic)
ANDA # 074681FLUCONAZOLE氟康唑TEVAFacility Addition02/06/2008片剂抗菌药
ANDA # 075710ALENDRONATE SODIUM阿仑膦酸钠TEVA PHARMSApproval02/06/2008片剂抗骨质增生
ANDA # 075960TRAMADOL HYDROCHLORIDE盐酸曲马多ACTAVIS ELIZABETHControl Supplement02/06/2008片剂镇痛药
ANDA # 076184ALENDRONATE SODIUM阿仑膦酸钠BARRApproval02/06/2008片剂抗骨质增生
ANDA # 077355CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE法莫替丁/碳酸钙/氢氧化镁PERRIGO R AND DApproval02/06/2008片剂（咀嚼）抗胃溃疡药
ANDA # 077615DIVALPROEX SODIUM双丙戊酸钠NU-PHARM, INC.Tentative Approval02/06/2008片剂（DR）抗癫痫(epilepsy)药
ANDA # 078031DICLOFENAC SODIUM双氯芬酸钠ALCONApproval02/06/2008滴眼剂NSAID
ANDA # 078290DIVALPROEX SODIUM双丙戊酸钠SANDOZTentative Approval02/06/2008片剂（DR）抗癫痫(epilepsy)药
NDA # 019813FENTANYL芬太尼ALZALabeling Revision02/07/2008膜剂（ER）镇痛药
NDA # 020151VENLAFAXINE HYDROCHLORIDE盐酸文拉法辛WYETH PHARMS INCLabeling Revision02/07/2008片剂抑郁症
NDA # 021445EZETIMIBE依泽替米贝MSP SINGAPORELabeling Revision02/07/2008片剂降脂药
NDA # 021947FENTANYL CITRATE柠檬酸芬太尼CEPHALONLabeling Revision02/07/2008片剂镇痛药
NDA # 050582DOXYCYCLINE HYCLATE盐酸多西环素MAYNE PHARMA INTLLabeling Revision02/07/2008胶囊剂（DR）抗生素(antibiotic)
ANDA # 077800LEVALBUTEROL HYDROCHLORIDE盐酸左旋沙丁胺醇DEY LPTentative Approval02/07/2008溶液剂支气管痉挛
NDA # 020941DOCOSANOL二十二烷醇 GLAXOSMITHKLINEManufacturing Change or Addition02/08/2008乳膏口、脸部疱疹
NDA # 021210LEVOTHYROXINE SODIUM甲状腺素钠STEVENS JFormulation Revision02/08/2008片剂甲状腺功能减退症
NDA # 021518SOLIFENACIN SUCCINATE索非那辛ASTELLASLabeling Revision02/08/2008片剂膀胱多动症
NDA # 021687EZETIMIBE; SIMVASTATIN依泽替米贝/辛伐他汀MSP SINGAPORELabeling Revision02/08/2008片剂降脂药
ANDA # 040613HOMATROPINE METHYLBROMIDE/HYDROCODONE BITARTRATE重酒石酸二氢可待因酮/溴甲后马托品HI TECH PHARMAApproval02/08/2008糖浆剂麻醉药
NDA # 013055ORPHENADRINE CITRATE枸橼酸奥芬那君 GRACEWAYLabeling Revision02/11/2008注射剂麻醉药/解痉药
NDA # 020151VENLAFAXINE HYDROCHLORIDE盐酸文拉法辛WYETH PHARMS INCLabeling Revision02/11/2008胶囊（缓释）抑郁症
ANDA # 065302AZITHROMYCIN阿奇霉素WOCKHARDTApproval02/11/2008片剂抗生素(antibiotic)
ANDA # 077491PRAVASTATIN SODIUM普伐他汀钠LEK PHARMS DDApproval02/11/2008片剂降脂药
ANDA # 077821ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE无水萘磺酸右丙氧芬、对乙酰氨基酚CONCORD LABS NJApproval02/11/2008片剂镇痛药
ANDA # 078371FINASTERIDE非那雄胺ACTAVIS TOTOWAApproval02/11/2008片剂前列腺增生
ANDA # 078391HYDROCHLOROTHIAZIDE氢氯噻嗪CADISTA PHARMSApproval02/11/2008胶囊剂利尿剂
ANDA # 078575BICALUTAMIDE比卡鲁胺SANDOZTentative Approval02/11/2008片剂前列腺癌(Prostate Cancer)
ANDA # 078597DIVALPROEX SODIUM双丙戊酸钠SUN PHARM INDS LTDTentative Approval02/11/2008片剂（DR）抗癫痫(epilepsy)药
NDA # 017892TRIAZOLAM三唑仑PHARMACIA AND UPJOHNLabeling Revision02/12/2008片剂催眠剂
ANDA # 040717PRIMIDONE扑米酮IMPAX LABSApproval02/12/2008片剂抗癫痫(epilepsy)药
ANDA # 040724PROMETHAZINE HYDROCHLORIDE盐酸异丙嗪IMPAX LABSApproval02/12/2008片剂抗过敏药
NDA # 020778NELFINAVIR MESYLATE甲磺奈非那韦AGOURONLabeling Revision02/13/2008粉末剂抗艾滋药
NDA # 021336SELEGILINE司来吉兰SOMERSETLabeling Revision02/13/2008膜剂（ER）帕金森症
ANDA # 078408VINORELBINE TARTRATE 酒石酸长春瑞滨EBEWE PHARMAApproval02/13/2008注射剂抗肿瘤药
ANDA # 078678GRANISETRON HYDROCHLORIDE盐酸格拉司琼ORCHID HLTHCAREApproval02/13/2008片剂化疗止吐药
NDA # 020683ETHINYL ESTRADIOL; LEVONORGESTREL左炔诺孕酮/炔雌醇WYETH PHARMS INCLabeling Revision02/14/2008片剂避孕药
NDA # 022081AMBRISENTAN安博森坦GILEADLabeling Revision02/14/2008片剂肺动脉高压
ANDA # 040699BENZTROPINE MESYLATE甲磺酸苯扎托品ACTAVIS TOTOWAApproval02/14/2008片剂帕金森症
ANDA # 078191RAMIPRIL雷米普利DR REDDYS LABS LTDTentative Approval02/14/2008胶囊剂高血压
ANDA # 078409LAMOTRIGINE拉莫三嗪SANDOZTentative Approval02/14/2008片剂抗癫痫(epilepsy)药
ANDA # 078692CETIRIZINE HYDROCHLORIDE盐酸西替利嗪SANDOZApproval02/14/2008咀嚼片剂抗过敏药
ANDA # 078922ZIDOVUDINE齐多夫定MATRIX LABS LTDApproval02/14/2008片剂乙肝
NDA # 019962METOPROLOL SUCCINATE琥珀酸美托洛尔ASTRAZENECAControl Supplement02/15/2008片剂（ER）高血压
NDA # 021277MOXIFLOXACIN HYDROCHLORIDE盐酸莫西沙星BAYER PHARMSLabeling Revision02/15/2008片剂抗生素(antibiotic)
NDA # 021085MOXIFLOXACIN HYDROCHLORIDE盐酸莫西沙星BAYER PHARMSLabeling Revision02/15/2008注射剂抗生素(antibiotic)
NDA # 021937EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE依法韦仑/恩曲他滨/替诺福韦酯GILEADLabeling Revision02/15/2008片剂抗艾滋药
NDA # 021985ALISKIREN HEMIFUMARATE富马酸阿利克仑NOVARTISLabeling Revision02/15/2008片剂高血压
NDA # 022078NIACIN/SIMVASTATIN烟酸辛伐他汀ABBOTTApproval02/15/2008片剂降脂药
NDA # 050781MINOCYCLINE HYDROCHLORIDE盐酸米诺环素ORAPHARMALabeling Revision02/15/2008粉剂（ER）抗生素(antibiotic)
ANDA # 065359CEFUROXIME AXETIL头孢呋辛酯ORCHID HLTHCAREApproval02/15/2008片剂抗生素(antibiotic)
ANDA # 078688BENDROFLUMETHIAZIDE; NADOLOL苄氟噻嗪/纳多洛尔MYLANApproval02/15/2008片剂高血压
FDA08年二月批准的药品（下）
(ANDA # 077724) PRAMIPEXOLE DIHYDROCHLORIDE盐酸普拉克索BARRApproval02/19/2008片剂/帕金森症
(NDA # 021548)FOSAMPRENAVIR CALCIUM福司安普那韦钙GLAXOSMITHKLINELabeling Revision02/20/2008/片剂/抗艾滋药
(NDA # 021567)ATAZANAVIR SULFATE阿扎那韦硫酸盐BRISTOL MYERS SQUIBBLabeling Revision02/20/2008胶囊/抗艾滋药
(NDA # 021692) TRAMADOL HYDROCHLORIDE盐酸曲马多BIOVAIL LABS INTLLabeling Revision02/20/2008片剂（ER）/镇痛药
(NDA # 022029)METHYL SALICYATE/MENTHOL水杨酸甲酯/薄荷脑HISAMITSU PHARMApproval02/20/2008贴剂/止痛药
(ANDA # 077219)IRINOTECAN HYDROCHLORIDE盐酸伊立替康WATSON LABSApproval02/20/2008注射剂/抗肿瘤药
(NDA # 016199) HYDROCORTISONE氢化可的松ANI PHARMSLabeling Revision02/21/2008灌肠剂/溃疡性结肠炎网友回复(NDA # 018771)HYDROXYPROPYL CELLULOSE羟丙基纤维素ATONLabeling Revision02/21/2008眼部插入剂/干眼综合症
(NDA # 021036) ZANAMIVIR扎那米韦GLAXOSMITHKLINELabeling Revision02/21/2008粉剂/抗病毒药
(NDA # 022028) COSYNTROPIN替可克肽SANDOZApproval02/21/2008注射剂/促皮质素类药
(NDA # 050441) CLINDAMYCIN PHOSPHATE克林霉素磷酸酯PHARMACIA AND UPJOHNLabeling Revision02/21/2008/注射剂/抗生素(antibiotic)
(NDA # 050536)ERYTHROMYCIN红霉素HOSPIRALabeling Revision02/21/2008胶囊（DR）抗生素(antibiotic)
(NDA # 050547)CEFOTAXIME SODIUM头孢噻肟钠SANOFI AVENTIS USLabeling Revision02/21/2008注射剂/抗生素(antibiotic)
(ANDA # 065396)CEFADROXIL/CEFADROXIL HEMIHYDRATE头孢羟氨苄/半水头孢羟氨苄LUPINApproval02/21/2008混悬剂/抗生素(antibiotic)
(ANDA # 078024) CIPROFLOXACIN; DEXTROSE环丙沙星/葡萄糖CLARIS LIFESCIENCESTentative Approval02/21/2008注射剂/抗生素(antibiotic)
(BLA # 125057) ADALIMUMAB阿达木单抗ABBOTTSupplement02/21/2008注射剂/关节炎
(NDA # 021071) ROSIGLITAZONE MALEATE马来酸罗格列酮SB PHARMCOLabeling Revision02/22/2008片剂/降糖药
(NDA # 050794) AZACITIDINE阿扎胞苷PHARMIONManufacturing Change or Addition02/22/2008注射剂/骨髓增生异常综合征
(BLA # 125085)BEVACIZUMAB贝伐单抗GENENTECHSupplement02/22/2008注射剂/抗肿瘤药
(NDA # 018163) TEMAZEPAM替马西泮TYCO HLTHCARELabeling Revision02/25/2008胶囊剂/催眠药
(NDA # 020895)SILDENAFIL CITRATE西地那非柠檬酸盐PFIZER IRELANDLabeling Revision02/25/2008片剂/抗ED药
(NDA # 021976) DARUNAVIR ETHANOLATE地瑞那韦TIBOTECFormulation Revision02/25/2008片剂/抗艾滋药
(ANDA # 077170)CERTIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE盐酸西替利嗪/盐酸伪麻黄碱TEVA PHARMSApproval02/25/2008片剂（ER）过敏性鼻炎
(ANDA # 077234)AMIODARONE HYDROCHLORIDE盐酸胺碘酮HIKMA FARMACEUTICAApproval02/25/2008注射剂/抗心律失常药
(NDA # 021067) MOMETASONE FUROATE糠酸莫米松SCHERINGLabeling Revision02/26/2008粉剂/皮质激素
(NDA # 021813)ESTRADIOL雌二醇 BRADLEY PHARMSPackage Change02/26/2008凝胶剂/雌激素
(NDA # 022044) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE磷酸西他列汀/盐酸二甲双胍MERCKEfficacy Supplement with Clinical Data to Support02/26/2008片剂/降糖药
(NDA # 022057) PROGESTERONE黄体酮FERRINGLabeling Revision02/26/2008凝胶剂/孕激素
(ANDA # 040814)CARBINOXAMINE MALEATE马来酸卡比沙明BOCA PHARMAApproval02/26/2008口服溶液/抗过敏药
(NDA # 050609) ERYTHROMYCIN LACTOBIONATE乳糖酸红霉素HOSPIRALabeling Revision02/26/2008注射剂/抗生素(antibiotic)
(NDA # 050742) IVERMECTIN伊维菌素MERCKManufacturing Change or Addition02/26/2008片剂/抗生素(antibiotic)
(ANDA # 077728)CALCIUM ACETATE醋酸钙ROXANEApproval02/26/2008胶囊/营养补充剂
(ANDA # 078058)ANASTROZOLE阿那曲唑TEVA PHARMSTentative Approval02/26/2008片剂/抗肿瘤药
(ANDA # 078098) TECHNETIUM TC-99M SESTAMIBI锝TC-99M司他比 MALLINCKRODTTentative Approval02/26/2008注射剂/诊断
(ANDA # 078155) SIMVASTATIN辛伐他汀ACCORD HLTHCAREApproval02/26/2008片剂/降脂药
(ANDA # 078478)TORSEMIDE托拉塞米SUN PHARM INDSApproval02/26/2008片剂/利尿剂
(NDA # 021729) ARIPIPRAZOLE阿立哌唑OTSUKAPatient Population Altered02/27/2008注射剂/精神分裂症
(NDA # 022101)ESOMEPRAZOLE MAGNESIUM埃索美拉唑ASTRAZENECAApproval02/27/2008混悬剂/ppi
(ANDA # 040797) MEPROBAMATE甲丙氨酯INVAGEN PHARMSApproval02/27/2008片剂/抗焦虑药
(NDA # 050317) LINCOMYCIN HYDROCHLORIDE盐酸林可霉素PHARMACIA AND UPJOHNLabeling Revision02/27/2008注射剂/(antibiotic)
(NDA # 050435) CARBENICILLIN INDANYL SODIUM苄茚西林钠 PFIZERLabeling Revision02/27/2008片剂/(antibiotic)
(ANDA # 065425)DEMECLOCYCLINE HYDROCHLORIDE盐酸去甲金霉素AMNEAL PHARMApproval02/27/2008片剂/抗生素(antibiotic)
(ANDA # 077260)IRINOTECAN HYDROCHLORIDE盐酸伊立替康TEVA PARENTERALApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 077776)IRINOTECAN HYDROCHLORIDE盐酸伊立替康APP PHARMSApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 077994)IRINOTECAN HYDROCHLORIDE盐酸伊立替康SANDOZApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 078037) GRANISETRON HYDROCHLORIDE盐酸格拉司琼CIPLA LIMITEDApproval02/27/2008片剂/抗肿瘤药
(ANDA # 078188) IRINOTECAN HYDROCHLORIDE盐酸伊立替康DABUR ONCOLOGY PLCApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 078224) AMLODIPINE BESYLATE苯磺酸氨氯地平MATRIX LABSApproval02/27/2008片剂/高血压
(ANDA # 078589)IRINOTECAN HYDROCHLORIDE盐酸伊立替康ACTAVIS TOTOWAApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 078745)RAMIPRIL雷米普利INVAGEN PHARMSTentative Approval02/27/2008胶囊/高血压
(ANDA # 078796)IRINOTECAN HYDROCHLORIDE盐酸伊立替康HOSPIRAApproval02/27/2008注射剂/抗肿瘤药
(ANDA # 078843)GRANISETRON HYDROCHLORIDE盐酸格拉司琼APOTEX INCApproval02/27/2008片剂/止吐药
(NDA # 019872) ACETAMINOPHEN对乙酰氨基酚MCNEIL CONSLabeling Revision02/28/2008片剂（ER）解热镇痛药
(NDA # 021318) TERIPARATIDE RECOMBINANT HUMAN人重组特立帕肽LILLYLabeling Revision02/28/2008注射剂/骨质疏松
(NDA # 021688) CINACALCET HYDROCHLORIDE盐酸西那卡塞AMGENLabeling Revision02/28/2008片剂/甲状旁腺机能亢进和高钙血症
(NDA # 021937) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE依发韦仑+恩曲他滨+替诺福韦酯GILEADLabeling Revision02/28/2008片剂/抗艾滋药
(NDA # 022033) FLUVOXAMINE MALEATE马来酸氟伏沙明SOLVAY PHARMSApproval02/28/2008片剂（ER）/抗抑郁药
(ANDA # 040751) IMIPRAMINE HYDROCHLORIDE盐酸丙咪嗪ACTAVIS TOTOWAApproval02/28/2008片剂/抗抑郁药
(ANDA # 078334) GRANISETRON HYDROCHLORIDE盐酸格拉司琼CYPRESS PHARMApproval02/28/2008口服溶液/止吐药
(ANDA # 078957) STAVUDINE司他夫定 INVAGEN PHARMSTentative Approval02/28/2008胶囊/抗艾滋药
(NDA # 010402)ESTROGENS, CONJUGATED共轭雌WYETH PHARMS INCLabeling Revision02/29/2008注射剂/雌缺乏症
(NDA # 020591) TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE群多普利/维拉帕米ABBOTTLabeling Revision02/29/2008片剂（ER）/高血压
(NDA # 021229)OMEPRAZOLE MAGNESIUM奥美拉唑镁ASTRAZENECAPackage Change02/29/2008片剂（DR）/PPI
(NDA # 021305) SODIUM IODIDE, I-131碘化钠DRAXIMAGELabeling Revision02/29/2008胶囊/诊断试剂
(NDA # 021348) MIGLUSTAT美格鲁特ACTELION PHARMSLabeling Revision02/29/2008胶囊/Gaucher病
(NDA # 021372) PALONOSETRON HYDROCHLORIDE盐酸帕洛诺司琼HELSINN HLTHCAREEfficacy Supplement with Clinical Data to Support02/29/2008注射剂/止吐药
(NDA # 021610) OXYMORPHONE HYDROCHLORIDE盐酸羟吗啡酮ENDO PHARMS Manufacturing Change or Addition02/29/2008片剂（ER）/镇痛药
（NDA # 021992) DESVENLAFAXINE SUCCINATE琥珀酸去甲文拉法辛WYETH PHARMS INCApproval02/29/2008片剂（ER）/抗抑郁症
(NDA # 022118)FENOFIBRATE非诺贝特LIFECYCLE PHARMA ASLabeling Revision02/29/2008片剂/降脂药
(ANDA # 078381) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE苯磺酸氨氯地平/盐酸贝那普利KALI LABSTentative Approval02/29/2008胶囊/高血压
(ANDA # 078566) GRANISETRON HYDROCHLORIDE盐酸格拉斯琼WOCKHARDT USAApproval02/29/2008注射剂/止吐药
(ANDA # 078886) EFAVIRENZ依法韦恩茨INVAGEN PHARMSTentative Approval02/29/2008片剂/抗艾滋药
08年三月批准的药品（上）
(NDA # 050638) PENICILLIN G POTASSIUM青霉素钾BAXTER HLTHCARELabeling Revision03/01/2008/注射剂/抗生素(antibiotic)
(NDA # 004782) ESTROGENS, CONJUGATED共轭雌激素 WYETH PHARMS INCLabeling Revision03/03/2008/片剂/雌激素缺乏症
(NDA # 020527) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE共轭雌激素；醋酸甲羟孕酮WYETH PHARMS INCLabeling Revision03/03/2008/片剂/雌激素缺乏症
(NDA # 021008) OCTREOTIDE ACETATE醋酸奥曲肽 NOVARTISNew or Modified Indication03/03/2008/注射剂/肢端肥大症/抗肿瘤药
（ANDA # 078313) ESCITALOPRAM OXALATE草酸s-西酞普兰WATSON LABSTentative Approval03/03/2008/片剂/抑郁症
(ANDA # 078639) FOMEPIZOLE甲吡唑SYNERX PHARMAApproval03/03/2008/注射剂/解毒剂
(ANDA # 078710) TELMISARTAN替米沙坦WATSON LABSTentative Approval03/03/2008/片剂/高血压
(NDA # 021779) ILOPROST依诺前列环素ACTELION PHARMLabeling Revision03/04/2008/溶液剂/肺动脉高压
(ANDA # 077329) OCTREOTIDE ACETATE醋酸奥曲肽SUN PHARM INDSApproval03/04/2008/注射剂/肢端肥大症/抗肿瘤药
(ANDA # 077982) ALENDRONATE SODIUM阿仑膦酸钠APOTEXTentative Approval03/04/2008/片剂/骨质疏松
(ANDA # 078433) GEMCITABINE HYDROCHLORID盐酸E吉西他宾SUN PHARM INDSTentative Approval03/04/2008注射剂/抗肿瘤
(NDA # 021083) SIROLIMUS西罗莫司WYETH PHARMS INCLabeling Revision03/05/2008/口服溶液/免疫抑制剂
(NDA # 021548) FOSAMPRENAVIR CALCIUM福沙那韦钙 GLAXOSMITHKLINELabeling Revision03/05/2008/片剂/抗AIDS
(NDA # 022116) FOSAMPRENAVIR CALCIUM福沙那韦钙 GLAXOLabeling Revision03/05/2008/混悬液/抗AIDS
(ANDA # 040673) PROMETHAZINE HYDROCHLORIDE盐酸异丙嗪ACTAVIS TOTOWAApproval03/05/2008/片剂/抗过敏药
(ANDA # 077991) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE盐酸西替利嗪；盐酸伪麻黄碱 SANDOZ Approval 03/05/2008/片剂ER/抗感冒药
(ANDA # 078276) OLMESARTAN MEDOXOMIL奥美沙坦酯MYLAN PHARMATentative Approval03/05/2008/片剂/降压药
(NDA # 015034) MEFENAMIC ACID甲芬那酸SCIELE PHARMA INCLabeling Revision03/06/2008/胶囊/NSAIDs
(NDA # 020990) SERTRALINE HYDROCHLORIDE盐酸舍曲林PFIZERLabeling Revision03/06/2008/片剂/抑郁症
(NDA # 021299) PAROXETINE MESYLATE甲磺酸帕罗西汀JDS PHARMSLabeling Revision03/06/2008/片剂/抑郁症
(NDA # 021436) ARIPIPRAZOLE阿立派唑OTSUKALabeling Revision03/06/2008/片剂/精神分裂症
(ANDA # 078537) FOMEPIZOLE甲吡唑NAVINTA LLCApproval03/06/2008/注射剂/解毒剂
(NDA # 020140) LEVOLEUCOVORIN左亚叶酸SPECTRUM PHARMSApproval03/07/2008/注射剂/抗肿瘤
(NDA # 020829) MONTELUKAST SODIUM孟鲁司特钠MERCKLabeling Revision03/07/2008/片剂/抗哮喘药
(NDA # 021976) DARUNAVIR ETHANOLATE地瑞那韦TIBOTECLabeling Revision03/07/2008/片剂/抗AIDS
(ANDA # 078465) PREDNISOLONE SODIUM PHOSPHATE泼尼松龙磷酸钠PHARM ASSOCApproval03/07/2008/溶液剂/抗炎药
(ANDA # 078671) NABUMETONE萘丁美酮INVAGEN PHARMSApproval03/07/2008/片剂/NSAIDs
(BLA # 103234) EPOETIN ALFA阿法依泊汀 AMGENSupplement03/07/2008/注射剂/贫血
(BLA # 103951) DARBEPOETIN ALFA阿法达贝泊汀AMGENSupplement03/07/2008/注射剂/贫血
(NDA # 018936) FLUOXETINE HYDROCHLORIDE盐酸氟西汀LILLYLabeling Revision03/09/2008/胶囊剂/抑郁症
(NDA # 020675) URSODIOL熊去氧胆酸AXCAN SCANDIPHARMPackage Change03/10/2008/片剂/胆结石
(NDA # 021266) VORICONAZOLE伏立康唑PFIZERLabeling Revision03/10/2008/混悬剂/抗菌药
(ANDA # 077763) CLOBETASOL PROPIONATE二丙酸氯倍他米松PERRIGO ISRAELApproval03/10/2008/喷雾剂/抗炎药
(ANDA # 078695) ROSIGLITAZONE MALEATE马来酸罗格列酮ROXANETentative Approval03/10/2008/片剂/降糖药
(NDA # 016151) METHENAMINE HIPPURATE马尿酸乌洛托品VATRING PHARMSLabeling Revision03/11/2008/片剂/抗菌药
(NDA # 018452) SULFAMETHOXAZOLE; TRIMETHOPRIM磺胺甲基异恶唑MONARCH PHARMSLabeling Revision03/11/2008/注射剂/抗生素(antibiotic)
(NDA # 019111) CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX氯苯那敏-磺化二乙烯苯-乙烯苯共聚物；二氢可待因酮-磺化二乙烯苯-乙烯苯共聚物UCB INCLabeling Revision03/11/2008/混悬剂ER/抗感冒药(NDA # 050717) FOSFOMYCIN TROMETHAMINE磷霉素缓血酸胺ZAMBONLabeling Revision03/11/2008/混悬剂/抗菌药
(ANDA # 065407) TOBRAMYCIN SULFATE硫酸妥布霉素AKORN STRIDESApproval03/11/2008/注射剂/抗生素(antibiotic)
(ANDA # 065470) MINOCYCLINE HYDROCHLORIDE盐酸米诺环素AUROBINDO PHARMAApproval03/11/2008/胶囊/抗生素(antibiotic)
(NDA # 017111) MOLINDONE HYDROCHLORIDE盐酸吗茚酮ENDO PHARMSLabeling Revision03/12/2008/胶囊/精神分裂症
(NDA # 020444) EPOPROSTENOL SODIUM依前列醇钠 GLAXOSMITHKLINELabeling Revision03/12/2008/注射剂/肺动脉高压
(ANDA # 040812) HYDROXYZINE羟嗪INVAGEN PHARMSApproval03/12/2008/片剂/抗焦虑药
(ANDA # 075982) TRAMADOL HYDROCHLORIDE盐酸曲马多PLIVAControl Supplement03/12/2008/片剂/镇痛药
(ANDA # 077413) PACLITAXEL紫杉醇PLIVA LACHEMAApproval03/12/2008/注射剂/抗肿瘤药
(ANDA # 077455) BUPROPION HYDROCHLORIDE盐酸安非他酮ACTAVISApproval03/12/2008/片剂ER/抗抑郁药
(NDA # 018117) TRIAMCINOLONE ACETONIDE醋酸曲安奈德ABBOTTLabeling Revision03/13/2008/喷雾剂/抗炎药
(NDA # 022047) QUETIAPINE FUMARATE富马酸喹硫平ASTRAZENECA Manufacturing Change or Addition03/13/2008/片剂ER/精神分裂症
(NDA # 050706) MEROPENEM美罗培南ASTRAZENECALabeling Revision03/13/2008/注射剂/抗生素(antibiotic)
(ANDA # 078564) GRANISETRON HYDROCHLORIDE盐酸格拉司琼WOCKHARentative Approval03/13/2008/注射剂/止吐药
(ANDA # 078902) PAROXETINE HYDROCHLORIDE盐酸帕罗西汀MYLANApproval03/13/2008/片剂/抗抑郁药
(NDA # 020986) INSULIN ASPART RECOMBINANT重组胰岛素(insulin)NOVO NORDISK INCPatient Population Altered03/14/2008/注射剂/降糖药(NDA # 021794) DAPSONE氨苯砜QLT USAEfficacy Supplement with Clinical Data to Support03/14/2008/凝胶剂/寻常痤疮
(ANDA # 077126) AMIFOSTINE阿米福汀 SUN PHARM INDSApproval03/14/2008/注射剂/抗肿瘤网友回复FDA08年三月批准的药品（下）
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(NDA # 020409) FLUNISOLIDE氟尼松IVAX RES LLCManufacturing Change or Addition03/17/2008/喷雾剂/肾上腺皮质激素
(NDA # 022207) MORPHINE SULFATE硫酸吗啡ROXANEApproval03/17/2008/片剂/镇痛药
(ANDA # 040723) ISOSORBIDE DINITRATE硝酸异山梨酯COREPHARMAApproval03/17/2008/片剂（ER）/心绞痛
(ANDA # 076128) OFLOXACIN氧氟沙星BAUSCH AND LOMBApproval03/17/2008/滴剂/抗生素(antibiotic)
(ANDA # 076616) OFLOXACIN氧氟沙星HI TECH PHARMAApproval03/17/2008/滴剂/抗生素(antibiotic)
(ANDA # 078222) OFLOXACIN氧氟沙星ALCONApproval03/17/2008/滴剂/抗生素(antibiotic)
(ANDA # 078308) ONDANSETRON HYDROCHLORIDE盐酸昂丹司琼CLARIS LIFESCIENCESApproval03/17/2008/注射剂/止吐药
(ANDA # 077138) CIPROFLOXACIN环丙沙星TEVA PARENTERAL Approval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 077753) CIPROFLOXACIN环丙沙星HOSPIRAApproval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 077888) CIPROFLOXACIN环丙沙星BAXTER HLTHCARE Approval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 078024) CIPROFLOXACIN环丙沙星CLARIS LIFESCIENCESApproval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 078114) CIPROFLOXACIN环丙沙星BEDFORDApproval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 078173) RIZATRIPTAN BENZOATE苯甲酸利扎曲坦MYLAN PHARMATentative Approval03/18/2008/口崩片/偏头痛
(ANDA # 078252) CIPROFLOXACIN环丙沙星 ACS DOBFAR INFO SA Approval03/18/2008/注射剂/抗生素(antibiotic)
(ANDA # 078476) FOSPHENYTOIN SODIUM磷苯妥英钠AKORN STRIDESApproval03/18/2008/注射剂/抗癫痫(epilepsy)药
(NDA # 021400) VARDENAFIL HYDROCHLORIDE盐酸伐地那非BAYER HLTHCARELabeling Revision03/19/2008/片剂/抗ED药
(ANDA # 040587) BENZONATATE苯佐那酯 SUN PHARM INDS INC Approval03/19/2008/胶囊/镇咳药
(ANDA # 065441) CEFEPIME HYDROCHLORIDE盐酸头孢吡肟ACS DOBFARApproval03/19/2008/注射剂/抗生素(antibiotic)
(ANDA # 077100) DIVALPROEX SODIUM双丙戊酸钠ZYDUS PHARMS USATentative Approval03/19/2008/片剂（DR）/抗癫痫(epilepsy)药
(NDA # 020692) SALMETEROL XINAFOATE沙美特罗羟萘甲酸盐GLAXO GRP LTDLabeling Revision03/20/2008/粉剂/平喘药
(NDA # 021223) ZOLEDRONIC ACID唑来膦酸NOVARTISPatient Population Altered03/20/2008/注射剂/抗肿瘤药
(NDA # 021254) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE丙酸氟替卡松，沙美特罗羟萘甲酸盐GLAXOSMITHKLINELabeling Revision03/20/2008/喷雾剂/平喘药
(NDA # 022056) OMEPRAZOLE/奥美拉唑ASTRAZENECA Approval03/20/2008/混悬剂/PPI
(NDA # 022177) STAVUDINE; LAMIVUDINE; NEVIRAPINE司他夫定/拉米夫定/奈韦拉平STRIDES ACROLABTentative Approval03/20/2008/片剂/抗艾滋药(NDA # 022249) BENDAMUSTINE HYDROCHLORIDE盐酸苯达莫司汀 CEPHALONApproval03/20/2008/注射剂/白血病
(ANDA # 040418) ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚，重酒石酸氢可酮MALLINCKRODTControl Supplement03/20/2008/口服溶液剂/镇痛药
(ANDA # 040535) ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE对乙酰氨基酚，盐酸氧可酮WATSON LABSPackage Change03/20/2008/片剂/镇痛药
(ANDA # 040813) ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚，重酒石酸氢可酮INTERPHARM Packager Addition03/20/2008/片剂/镇痛药
(ANDA # 076642) HYDROCODONE BITARTRATE; IBUPROFEN重酒石酸氢可酮，布洛芬INTERPHARMPackager Addition03/20/2008/片剂/镇痛药
(ANDA # 076899) SULFAMETHOXAZOLE; TRIMETHOPRIM磺胺甲恶唑-甲氧苄啶 INTERPHARMPackager Addition03/20/2008/片剂/抗生素(antibiotic)
(ANDA # 077094) RIBAVIRIN利巴韦林ZYDUS PHARMS USAPackaging Addition03/20/2008/片剂/抗病毒药
(ANDA # 077289) CITALOPRAM HYDROBROMIDE氢溴酸西酞普兰INTERPHARMPackager Addition03/20/2008/片剂/抗抑郁药
(ANDA # 077743) RIBAVIRIN利巴韦林SANDOZControl Supplement03/20/2008/片剂/抗病毒药
(ANDA # 077779) METOPROLOL SUCCINATE酒石酸美托洛尔 KV PHARMApproval03/20/2008/片剂（ER）/降压药
(ANDA # 077824) RANITIDINE HYDROCHLORIDE盐酸雷尼替丁INTERPHARMPackager Addition03/20/2008/片剂/H2受体拮抗剂
(ANDA # 077880) METFORMIN HYDROCHLORIDE盐酸二甲双胍INTERPHARMPackager Addition03/20/2008/片剂/降糖药
(ANDA # 078149) ASPIRIN; BUTALBITAL; CAFFEINE阿司匹林/布他比妥/咖啡因MUTUAL PHARMFacility Addition03/20/2008/胶囊/镇痛药
(ANDA # 089883) ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚，重酒石酸氢可酮 WATSON LABS Manufacturing Revision03/20/2008/片剂/镇痛药
(NDA # 020232) ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE对乙酰氨基酚,布他比妥,咖啡因,磷酸可待因WATSON PHARMSLabeling Revision03/21/2008/胶囊/镇痛药
(NDA # 021235) FLUOXETINE HYDROCHLORIDE盐酸氟西汀LILLYLabeling Revision03/21/2008/口服溶液/抗抑郁药
(NDA # 021520) FLUOXETINE HYDROCHLORIDE; OLANZAPINE盐酸氟西汀；奥氮平LILLYLabeling Revision03/21/2008/胶囊/抗抑郁药
(ANDA # 040847) GLYCOPYRROLATE格隆溴胺INDICUS PHARMA Approval03/21/2008/片剂/抗胆碱药
(ANDA # 040875) PHENTERMINE HYDROCHLORIDE盐酸苯丁胺KVK TECHApproval03/21/2008/胶囊/食欲抑制剂
(ANDA # 078014) ONDANSETRON HYDROCHLORIDE盐酸昂丹司琼TARO PHARMS IRELANDApproval03/21/2008/注射剂/止吐药
(ANDA # 078926) GABAPENTIN加巴喷丁ZYDUS PHARMS USA INCTentative Approval03/21/2008/片剂/抗癫痫(epilepsy)药
(NDA # 017531) TRIMETHOBENZAMIDE HYDROCHLORIDE盐酸三甲氧苯酰胺 KING PHARMSLabeling Revision03/24/2008/胶囊/术后恶心呕吐
(NDA # 021168) DIVALPROEX SODIUM双丙戊酸钠ABBOTTPatient Population Altered03/24/2008/片剂（ER）/抗癫痫(epilepsy)药
(NDA # 021337) ERTAPENEM SODIUM厄他培南钠MERCK Labeling Revision03/24/2008/注射剂/抗生素(antibiotic)
(NDA # 021777) CYCLOBENZAPRINE HYDROCHLORIDE盐酸环苯扎林ANESTALabeling Revision03/24/2008/胶囊（ER）/肌松药
(NDA # 022267) DIVALPROEX SODIUM双丙戊酸钠ABBOTT Approval03/24/2008/片剂（ER）/抗癫痫(epilepsy)药
(NDA # 021567) ATAZANAVIR SULFATE硫酸阿扎那韦BRISTOL MYERS SQUIBBPatient Population Altered03/25/2008/胶囊/抗艾滋药
(BLA # 125019) IBRITUMOMAB TIUXETAN伊莫单抗IDEC PHARMACEUTICALS CORPSupplement03/25/2008/注射剂/抗肿瘤药
(NDA # 020983) ALBUTEROL SULFATE硫酸沙丁胺醇 GLAXOSMITHKLINEEfficacy Supplement with Clinical Data to Support 03/26/2008/喷雾剂/支气管痉挛
(ANDA # 065327) CEFPROZIL头孢丙烯APOTEX INC Approval03/26/2008/片剂/抗生素(antibiotic)
(ANDA # 076509) FENOFIBRATE非诺贝特IMPAX LABS Approval03/26/2008/片剂/降脂药
(ANDA # 040704) BETHANECHOL CHLORIDE氯贝丁酯 LANNETT Approval03/27/2008/片剂/降脂药
(NDA # 050706) MEROPENEM美罗培南 ASTRAZENECA Labeling Revision03/27/2008/注射剂/抗生素(antibiotic)
(NDA # 050726) AMOXICILLIN; CLAVULANATE POTASSIUM阿莫西林/克拉维酸钾GLAXOSMITHKLINELabeling Revision03/27/2008注射剂/抗生素(antibiotic)/β-内酰胺类/β-内酰胺酶抑制剂
(NDA # 050630) CILASTATIN SODIUM; IMIPENEM亚胺培南西司他丁钠MERCKLabeling Revision03/28/2008咀嚼片/抗生素(antibiotic)/β-内酰胺类/β-内酰胺酶抑制剂
(NDA # 050761) AMOXICILLIN阿莫西林GLAXOSMITHKLINELabeling Revision03/28/2008/咀嚼片/抗生素(antibiotic)
(ANDA # 065390) RIFAMPIN利福平LANNETTApproval03/28/2008/胶囊/抗生素(antibiotic)
(ANDA # 078525) LAMOTRIGINE拉莫三嗪TARO PHARM INDSTentative Approval03/28/2008/片剂/抗癫痫(epilepsy)药
(NDA # 021319) DUTASTERIDE度他雄胺GLAXOSMITHKLINELabeling Revision03/31/2008/胶囊剂/良性前列腺增生（BPH）
(NDA # 022009) AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE阿沃苯松/依莰舒/奥克立林/二氧化钛 LOREAL USAApproval03/31/2008/乳膏OTC/防晒剂
(NDA # 022064) LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪UCB INCLabeling Revision03/31/2008/片剂/H1受体拮抗剂
(ANDA # 040842) HYDROXYZINE HYDROCHLORIDE盐酸羟吗啡酮NORTHSTAR HLTHCAREApproval03/31/2008/片剂/镇痛药
(ANDA # 078084) METRONIDAZOLE甲硝唑 CLARIS LIFESCIENCESApproval03/31/2008/注射剂/抗厌氧菌与抗滴虫药
(ANDA # 040876) PHENTERMINE HYDROCHLORIDE盐酸苯丁胺 NORTHSTAR HLTHCAREApproval03/31/2008/片剂/食欲抑制剂
(NDA # 020090) FLUCONAZOLE氟康唑PFIZERLabeling Revision03/31/2008/口服混悬剂/抗真菌药网友回复so many!!!!!:rol::rol:
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