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FDA08年批准的药品
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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 # 021924 LEVOTHYROXINE SODIUM甲状腺素钠 INST BIOCHIMIQUE Supplement 01/01/2008 胶囊 甲状腺功能不足病，垂腺TSH抑制 NDA # 018031 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE氢氯噻嗪/盐酸普萘洛尔 WYETH PHARMS INC Labeling Revision 01/02/2008 片剂 高血压 NDA # 020356 NISOLDIPINE尼索地平 SCIELE PHARMA INC Formulation Revision 01/02/2008 胶囊剂（ER） 高血压 NDA # 021438 PROPRANOLOL HYDROCHLORIDE盐酸普萘洛尔 RELIANT PHARMS Labeling Revision 01/02/2008 片剂（ER） 高血压 NDA # 022044 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE盐酸二甲双胍磷酸西他列汀 MERCK Labeling Revision 01/02/2008 片剂 2型糖尿病 NDA # 020375 ESTRADIOL雌二醇 BAYER HLTHCARE Labeling Revision 01/03/2008 膜剂（ER） 雌激素 NDA # 020522 SOMATROPIN RECOMBINANT基因重组人生长激素 GENENTECH Manufacturing Change or Addition 01/03/2008 注射剂 生长素 ANDA # 077963 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 TEVA PARENTERAL Approval 01/03/2008 注射剂 化疗止吐 ANDA # 078596 METFORMIN HYDROCHLORIDE盐酸二甲双胍 INTERPHARM Approval 01/03/2008 片剂（ER） 降糖药 ANDA # 077643 TOPIRAMATE HYDROCHLORIDE盐酸托吡酯 COBALT Tentative Approval 01/04/2008 片剂 抗癫痫药 ANDA # 078769 IBUPROFEN; OXYCODONE HYDROCHLORIDE布洛芬盐酸羟考酮 ACTAVIS ELIZABETH Approval 01/04/2008 片剂 镇痛药 NDA # 050207 ERYTHROMYCIN ETHYLSUCCINATE琥乙红霉素 ABBOTT Labeling Revision 01/05/2008 颗粒剂 抗生素 NDA # 050611 ERYTHROMYCIN红霉素 ABBOTT Labeling Revision 01/05/2008 片剂，包衣颗粒 抗生素 NDA # 021368 TADALAFIL他达那非 LILLY New Dosage Regimen 01/07/2008 片剂 性勃起功能障碍 ANDA # 065434 CEFDINIR头孢地尼 AUROBINDO PHARMA Approval 01/07/2008 胶囊剂 抗生素 ANDA # 077062 FENTANYL芬太尼 ABRIKA PHARMS Control Supplement 01/07/2008 膜剂（ER） 镇痛药 ANDA # 078151 TERBUTALINE SULFATE硫酸特布他林 AKORN Approval 01/07/2008 注射剂 平喘药 NDA # 017963 METOPROLOL TARTRATE酒石酸美托洛尔 NOVARTIS Labeling Revision 01/08/2008 片剂 高血压 NDA # 018303 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE氢氯噻嗪酒石酸美托洛尔 NOVARTIS Labeling Revision 01/08/2008 片剂 高血压 NDA # 019649 RIMANTADINE HYDROCHLORIDE盐酸金刚乙胺 FOREST LABS Labeling Revision 01/08/2008 片剂 抗病毒 ANDA # 077129 RIVASTIGMINE TARTRATE酒石酸卡巴拉汀 WATSON LABS Approval 01/08/2008 胶囊剂 抗AD药 ANDA # 077297 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 SICOR PHARMS Tentative Approval 01/08/2008 注射剂 化疗止吐 ANDA # 077917 PRAVASTATIN SODIUM 普伐他汀钠 LUPIN PHARMS Approval 01/08/2008 胶囊剂 高脂血症 ANDA # 078090 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 ABRAXIS PHARM Tentative Approval 01/08/2008 注射剂 化疗止吐 ANDA # 078403 SERTRALINE HYDROCHLORIDE盐酸舍曲林 WOCKHARDT Approval 01/08/2008 片剂 抗抑郁药 NDA # 021490 ETHINYL ESTRADIOL; NORETHINDRONE炔雌醇炔诺酮 WARNER CHILCOTT Labeling Revision 01/09/2008 咀嚼片 避孕药 ANDA # 040094 ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚+重酒石酸可待因酮 WATSON LABS Supplier Addition 01/09/2008 片剂 镇痛药 ANDA # 077051 FENTANYL芬太尼 LAVIPHARM LABS Control Supplement 01/09/2008 膜剂（ER） 镇痛药 ANDA # 076507 FLUCONAZOLE氟康唑 TARO Control Supplement 01/09/2008 片剂 抗菌药 ANDA # 078339 GEMCITABINE吉西他宾 HOSPIRA INC Tentative Approval 01/09/2008 注射剂 抗肿瘤药 NDA # 021610 OXYMORPHONE HYDROCHLORIDE盐酸羟吗啡酮 ENDO PHARMS Control Supplement 01/10/2008 片剂（ER） 镇痛药 NDA # 021658 CICLESONIDE环索奈德 NYCOMED US INC Approval 01/10/2008 吸入剂 平喘药 ANDA # 065342 CEFTRIAXONE头孢曲松 HIKMA FARMACEUTICA Approval 01/10/2008 注射剂 抗生素 ANDA # 065372 POLYMYXIN B SULFATE硫酸多粘菌素B ABRAXIS PHARM PRODS Approval 01/10/2008 注射剂 多肽类抗生素 ANDA # 078213 PROPRANOLOL HYDROCHLORIDE普萘洛尔 NORTHSTAR HLTHCARE Approval 01/10/2008 片剂 高血压 NDA # 021153 ESOMEPRAZOLE MAGNESIUM埃索美拉唑镁 ASTRAZENECA Labeling Revision 01/11/2008 胶囊（DR） PPI NDA # 021773 EXENATIDE SYNTHETIC类高血糖因子 AMYLIN Labeling Revision 01/11/2008 注射剂 降糖药 ANDA # 065305 CEFTRIAXONE SODIUM头孢曲松钠 LUITPOLD Approval 01/11/2008 注射剂 抗生素 ANDA # 077344 DONEPEZIL HYDROCHLORIDE盐酸多奈哌齐 TEVA PHARMS Tentative Approval 01/11/2008 片剂 抗AD药 ANDA # 077620 GLIPIZIDE; METFORMIN HYDROCHLORIDE吡嗪双胍片 CARACO Approval 01/11/2008 片剂 降糖药 ANDA # 077631 CETIRIZINE HYDROCHLORIDE盐酸西替利嗪 CARACO Approval 01/11/2008 片剂 抗过敏药 ANDA # 078069 OXCARBAZEPINE奥卡西平 BRECKENRIDGE PHARM Approval 01/11/2008 片剂 抗癫痫药 NDA # 020998 CELECOXIB塞来昔布 GD SEARLE Labeling Revision 01/14/2008 胶囊剂 关节炎 NDA # 021083 SIROLIMUS西罗莫司 WYETH PHARMS INC Efficacy Supplement with Clinical Data to Support 01/14/2008 口服溶液 免疫抑制剂 ANDA # 076273 CLOPIDOGREL BISULFATE氯吡格雷硫酸氢盐 DR REDDYS LABS INC Approval 01/14/2008 片剂 抗凝血药 ANDA # 078145 KETOROLAC TROMETHAMINE酮咯酸氨丁三醇 LUITPOLD Approval 01/14/2008 注射剂 止痛药 ANDA # 078198 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 APOTEX Tentative Approval 01/14/2008 注射剂 化疗止吐 BLA # 125104 NATALIZUMAB那他珠单抗 BIOGEN IDEC Supplement 01/14/2008 注射剂 抗肿瘤药 08年一月批准的药品（下） NDA # 021350 FENOFIBRATE非诺贝特 SKYEPHARMA AG Labeling Revision 01/15/2008 片剂 高脂血症 ANDA # 077793 PRAVASTATIN SODIUM普伐他汀钠 TEVA PHARMS Approval 01/15/2008 片剂 高脂血症 ANDA # 078343 CETIRIZINE HYDROCHLORIDE盐酸西替利嗪 DR REDDYS LABS LTD Approval 01/15/2008 片剂 抗过敏药 ANDA # 078662 DONEPEZIL HYDROCHLORIDE盐酸多奈哌齐 ROXANE Tentative Approval 01/15/2008 片剂 抗AD药 NDA # 021071 ROSIGLITAZONE MALEATE马来酸罗格列酮 SB PHARMCO Labeling Revision 01/16/2008 片剂 降糖药 NDA # 021426 SOMATROPIN RECOMBINANT基因重组人生长激素 SANDOZ Formulation Revision 01/16/2008 注射剂 生长素 ANDA # 077570 FLUTICASONE PROPIONATE丙酸氟替卡松 HI TECH PHARMA Approval 01/16/2008 气雾剂 糖皮质激素 ANDA # 078143 FLUOXETINE HYDROCHLORIDE盐酸氟西汀 WOCKHARDT Approval 01/16/2008 胶囊剂 抗抑郁药 ANDA # 078477 AMLODIPINE BESYLATE苯磺酸氨氯地平 INTERPHARM Approval 01/16/2008 片剂 高血压 ANDA # 078598 CIPROFLOXACIN HYDROCHLORIDE盐酸环丙沙星 PHARMAFORCE Approval 01/16/2008 滴剂 抗生素 NDA # 021087 OSELTAMIVIR PHOSPHATE磷酸奥司他韦 ROCHE Labeling Revision 01/17/2008 混悬液 抗病毒药 NDA # 021471 AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE阿沃苯松/依莰舒/奥克立林/二氧化钛 LOREAL USA Labeling Revision 01/17/2008 乳膏 防晒剂 NDA # 022067 PREDNISOLONE ACETATE醋酸泼尼松龙 TARO Approval 01/17/2008 混悬液 糖皮质激素 ANDA # 076740 NIMODIPINE尼莫地平 BANNER PHARMACAPS Approval 01/17/2008 胶囊 高血压 NDA # 019537 CIPROFLOXACIN HYDROCHLORIDE盐酸环丙沙星 BAYER PHARMS Labeling Revision 01/18/2008 片剂 抗生素 NDA # 020780 CIPROFLOXACIN 环丙沙星 BAYER PHARMS Labeling Revision 01/18/2008 混悬液 抗生素 NDA # 021176 COLESEVELAM HYDROCHLORIDE盐酸考来维仑 DAIICHI SANKYO New or Modified Indication 01/18/2008 片剂 降糖药 NDA # 021180 ETHINYL ESTRADIOL; NORELGESTROMIN乙炔雌二醇/甲基孕酮 ORTHO MCNEIL PHARM Labeling Revision 01/18/2008 膜剂（ER） 避孕药 NDA # 021229 OMEPRAZOLE MAGNESIUM奥美拉唑镁 ASTRAZENECA Labeling Revision 01/18/2008 片剂（ER） PPI NDA # 021473 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE环丙沙星，盐酸环丙沙星 BAYER PHARMS Labeling Revision 01/18/2008 片剂（ER） 抗生素 NDA # 022107 ALISKIREN HYDROCHLOROTHIAZIDE阿利吉仑/氢氯噻嗪 NOVARTIS PHARMS Approval 01/18/2008 片剂 高血压 NDA # 022187 ETRAVIRINE伊他韦恩 TIBOTEC Approval 01/18/2008 片剂 抗病毒药 ANDA # 077255 LANSOPRAZOLE兰索拉唑 TEVA PHARMS Tentative Approval 01/18/2008 胶囊剂（DR） PPI BLA # 103792 TRASTUZUMAB曲妥珠单抗 GENENTECH Supplement 01/18/2008 注射剂 抗肿瘤药 BLA # 125057 ADALIMUMAB阿达木单抗 ABBOTT Supplement 01/18/2008 注射剂 关节炎、银屑病等 NDA # 017628 TOLMETIN SODIUM托尔米汀钠 ORTHO MCNEIL PHARM Labeling Revision 01/22/2008 胶囊剂 NSAID NDA # 021506 MICAFUNGIN SODIUM米卡芬净钠 ASTELLAS New or Modified Indication 01/22/2008 注射剂 抗菌药 NDA # 050580 AZTREONAM氨曲南 BRISTOL MYERS SQUIBB Labeling Revision 01/22/2008 注射剂 抗生素 NDA # 021538 SOMATROPIN rDNA ORIGINAL人生长激素原始rDNA CANGENE CORP Approval 01/23/2008 注射剂 生长素 NDA # 050813 AMOXICILLIN阿莫西林 MIDDLEBROOK PHARMA Approval 01/23/2008 片剂（ER） 抗生素 ANDA # 077453 OXYTOCIN缩宫素 TEVA PARENTERAL Approval 01/24/2008 注射剂 引产、产后出血等 BLA # 103705 RITUXIMAB利妥昔单抗 GENENTECH Supplement 01/24/2008 注射剂 抗肿瘤药 NDA # 018827 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE二丙酸倍他米松克霉唑 SCHERING Labeling Revision 01/25/2008 乳膏 抗菌药 NDA # 020010 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE二丙酸倍他米松克霉唑 SCHERING PLOUGH RES Labeling Revision 01/25/2008 洗液 抗菌药 NDA # 021166 ESTRADIOL雌二醇 ASCEND Labeling Revision 01/25/2008 凝胶剂 雌激素 NDA # 022023 FOSAPREPITANT DIMEGLUMINE阿瑞吡坦二甲葡胺 MERCK CO INC Approval 01/25/2008 粉末剂 止吐药 ANDA # 040517 METHADONE HYDROCHLORIDE盐酸美沙酮 MALLINCKRODT Control Supplement 01/26/2008 片剂 镇静剂 ANDA # 040545 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE对乙酰氨基酚/盐酸羟氢可待酮 MALLINCKRODT Control Supplement 01/26/2008 片剂 镇静剂 ANDA # 075618 ACETAMINOPHEN/BUTALBITAL/CAFFEINE/CODEINE PHOSPHATE对乙酰氨基酚,布他比妥,咖啡因,磷酸可待因 WEST WARD Supplier Addition 01/26/2008 胶囊剂 镇静剂 ANDA # 087757 ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚+重酒石酸可待因酮 SCHWARZ PHARMA Control Supplement 01/26/2008 片剂 镇痛药 NDA # 020639 QUETIAPINE FUMARATE富马酸奎硫平 ASTRAZENECA Labeling Revision 01/28/2008 片剂 精神分裂症 NDA # 022157 LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪 UCB INC Approval 01/28/2008 口服溶液 抗过敏药 ANDA # 040762 PHENDIMETRAZINE TARTRATE酒石酸苯甲曲秦 AMIDE PHARM Approval 01/28/2008 片剂 肥胖症 ANDA # 040874 DIPYRIDAMOLE 双嘧达莫 ZYDUS PHARMS USA INC Approval 01/28/2008 片剂 抗血栓 ANDA # 065185 BLEOMYCIN SULFATE硫酸博来霉素 ABRAXIS PHARM Approval 01/28/2008 注射剂 抗肿瘤抗生素 NDA # 021476 ESZOPICLONE右佐匹克隆 SEPRACOR Labeling Revision 01/29/2008 片剂 失眠 ANDA # 040776 DEXTROAMPHETAMINE SULFATE右旋苯丙胺硫酸盐 OUTLOOK PHARMS Approval 01/29/2008 口服溶液 肥胖症 ANDA # 077630 TAMSULOSIN HYDROCHLORIDE盐酸坦索罗辛 TEVA PHARMS Tentative Approval 01/29/2008 胶囊剂 前列腺疾病 ANDA # 078066 CALCITRIOL骨化三醇 AKORN Approval 01/29/2008 注射剂 维生素类药 ANDA # 078242 TECHNETIUM TC-99M MEBROFENIN KIT锝99甲溴菲宁试剂盒 CIS Approval 01/29/2008 —— 诊断用药 ANDA # 078850 LAMIVUDINE拉米夫定 INVAGEN PHARMS Tentative Approval 01/29/2008 片剂 乙肝 NDA # 020151 VENLAFAXINE HYDROCHLORIDE盐酸维拉法辛 WYETH PHARMS INC Labeling Revision 01/30/2008 片剂 抗抑郁药 NDA # 020699 VENLAFAXINE HYDROCHLORIDE盐酸维拉法辛 WYETH PHARMS INC Labeling Revision 01/30/2008 胶囊剂（ER） 抗抑郁药 ANDA # 040732 PHENYTOIN SODIUM苯妥英钠 WOCKHARDT USA Approval 01/30/2008 胶囊剂 抗癫痫药 ANDA # 077693 CALCIUM ACETATE醋酸钙 ROXANE Approval 01/30/2008 片剂 营养补充剂 ANDA # 078075 BRIMONIDINE TARTRATE酒石酸溴莫尼定 SANDOZ Approval 01/30/2008 滴眼液 青光眼 ANDA # 078327 SUMATRIPTAN SUCCINATE舒马坦琥珀酸盐 AUROBINDO PHARMA Tentative Approval 01/30/2008 片剂 偏头痛 ANDA # 078725 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 MYLAN Approval 01/30/2008 注射剂 抗肿瘤药 NDA # 020683 ETHINYL ESTRADIOL; LEVONORGESTREL炔雌醇左炔诺孕酮 WYETH PHARMS INC Labeling Revision 01/31/2008 片剂 避孕药 NDA # 021437 EPLERENONE依普利酮 GD SEARLE LLC Patient Population Altered 01/31/2008 片剂 高血压 NDA # 021928 VARENICLINE TARTRATE酒石酸瓦伦尼克林 PFIZER INC Labeling Revision 01/31/2008 片剂 戒烟药 NDA # 022064 LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪 UCB INC Labeling Revision 01/31/2008 片剂 抗过敏药 ANDA # 077260 IRINOTECAN HYDROCHLORIDE盐酸伊立替康 TEVA PARENTERAL Tentative Approval 01/31/2008 注射剂 抗肿瘤药 ANDA # 077760 PROPRANOLOL HYDROCHLORIDE盐酸普萘洛尔 HIKMA FARMACEUTICA Approval 01/31/2008 注射剂 高血压 ANDA # 078002 CAFFEINE CITRATE柠檬酸咖啡因 ABRAXIS PHARM PRODS Approval 01/31/2008 口服溶液 兴奋剂 ANDA # 078081 AMLODIPINE BESYLATE苯磺酸氨氯地平 MUTUAL PHARMA Approval 01/31/2008 片剂 高血压 ANDA # 078619 FLUOXETINE HYDROCHLORIDE盐酸氟西汀 AUROBINDO PHARMA Approval 01/31/2008 胶囊剂 抗抑郁药 ANDA # 078626 SERTRALINE HYDROCHLORIDE盐酸舍曲林 MATRIX LABS LTD Approval 01/31/2008 片剂 抗抑郁药 ANDA # 078787 GABAPENTIN加巴喷丁 AUROBINDO PHARM Approval 01/31/2008 胶囊剂 抗癫痫药 [ Last edited by xiaohezi7844 on 2008-4-3 at 21:19 ] |
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FDA08年二月批准的药品（上） NDA # 020564 LAMIVUDINE拉米夫定 GLAXOSMITHKLINE Patient Population Altered 02/01/2008 片剂 慢乙肝 NDA # 007638 CHLORPHENIRAMINE MALEATE马来酸氯苯那敏 SCHERING PLOUGH Labeling Revision 02/04/2008 片剂（ER） 抗过敏药 NDA # 017058 METHADONE HYDROCHLORIDE盐酸美沙酮 ROXANE Labeling Revision 02/04/2008 片剂 戒毒药 NDA # 017116 METHADONE HYDROCHLORIDE盐酸美沙酮 MALLINCKRODT Labeling Revision 02/04/2008 浓缩液 戒毒药 NDA # 018063 NADOLOL纳多洛尔 KING PHARMS Labeling Revision 02/04/2008 片剂 高血压 NDA # 021272 TREPROSTINIL SODIUM曲前列环素钠 UNITED THERAP Labeling Revision 02/04/2008 注射剂 肺动脉高压 ANDA # 078785 ATAZANAVIR SULFATE阿扎那韦硫酸盐 EMCURE PHARMA Tentative Approval 02/04/2008 胶囊剂 抗病毒药 NDA # 021140 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE盐酸洛哌丁胺/二甲基硅油 MCNEIL CONS Labeling Revision 02/05/2008 片剂 止泻药 NDA # 021266 VORICONAZOLE伏立康唑 PFIZER Labeling Revision 02/05/2008 片剂 抗菌药 NDA # 021514 METHYLPHENIDATE哌甲酯 SHIRE Labeling Revision 02/05/2008 膜剂（ER） ADHD（多动） NDA # 021730 LEVALBUTEROL TARTRATE左旋沙丁胺醇酒石酸盐 SEPRACOR Control Supplement 02/05/2008 气雾剂 支气管痉挛 NDA # 021881 ASCORBIC 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 PHARMS Labeling Revision 02/05/2008 口服溶液 清肠 ANDA # 065323 CEFUROXIME AXETIL头孢呋辛酯 RANBAXY Approval 02/05/2008 口服混悬剂 抗生素 ANDA # 077830 ESOMEPRAZOLE MAGNESIUM埃索美拉唑镁 RANBAXY Tentative Approval 02/05/2008 胶囊（DR） PPI NDA # 017577 OXYBUTYNIN CHLORIDE盐酸奥昔布宁 ALZA Labeling Revision 02/06/2008 片剂 膀胱炎、尿道炎 NDA # 020238 CIMETIDINE甲腈咪胺 GLAXOSMITHKLINE Labeling Revision 02/06/2008 片剂 抗胃溃疡药 NDA # 050006 DOXYCYCLINE多西环素 PFIZER Labeling Revision 02/06/2008 混悬剂 抗生素 NDA # 050007 DOXYCYCLINE HYCLATE盐酸多西环素 PFIZER Labeling Revision 02/06/2008 胶囊剂 抗生素 NDA # 050480 DOXYCYCLINE CALCIUM多西环素钙 PFIZER Labeling Revision 02/06/2008 混悬剂 抗生素 ANDA # 074681 FLUCONAZOLE氟康唑 TEVA Facility Addition 02/06/2008 片剂 抗菌药 ANDA # 075710 ALENDRONATE SODIUM阿仑膦酸钠 TEVA PHARMS Approval 02/06/2008 片剂 抗骨质增生 ANDA # 075960 TRAMADOL HYDROCHLORIDE盐酸曲马多 ACTAVIS ELIZABETH Control Supplement 02/06/2008 片剂 镇痛药 ANDA # 076184 ALENDRONATE SODIUM阿仑膦酸钠 BARR Approval 02/06/2008 片剂 抗骨质增生 ANDA # 077355 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE法莫替丁/碳酸钙/氢氧化镁 PERRIGO R AND D Approval 02/06/2008 片剂（咀嚼） 抗胃溃疡药 ANDA # 077615 DIVALPROEX SODIUM双丙戊酸钠 NU-PHARM, INC. Tentative Approval 02/06/2008 片剂（DR） 抗癫痫药 ANDA # 078031 DICLOFENAC SODIUM双氯芬酸钠 ALCON Approval 02/06/2008 滴眼剂 NSAID ANDA # 078290 DIVALPROEX SODIUM双丙戊酸钠 SANDOZ Tentative Approval 02/06/2008 片剂（DR） 抗癫痫药 NDA # 019813 FENTANYL芬太尼 ALZA Labeling Revision 02/07/2008 膜剂（ER） 镇痛药 NDA # 020151 VENLAFAXINE HYDROCHLORIDE盐酸文拉法辛 WYETH PHARMS INC Labeling Revision 02/07/2008 片剂 抑郁症 NDA # 021445 EZETIMIBE依泽替米贝 MSP SINGAPORE Labeling Revision 02/07/2008 片剂 降脂药 NDA # 021947 FENTANYL CITRATE柠檬酸芬太尼 CEPHALON Labeling Revision 02/07/2008 片剂 镇痛药 NDA # 050582 DOXYCYCLINE HYCLATE盐酸多西环素 MAYNE PHARMA INTL Labeling Revision 02/07/2008 胶囊剂（DR） 抗生素 ANDA # 077800 LEVALBUTEROL HYDROCHLORIDE盐酸左旋沙丁胺醇 DEY LP Tentative Approval 02/07/2008 溶液剂 支气管痉挛 NDA # 020941 DOCOSANOL二十二烷醇 GLAXOSMITHKLINE Manufacturing Change or Addition 02/08/2008 乳膏 口、脸部疱疹 NDA # 021210 LEVOTHYROXINE SODIUM甲状腺素钠 STEVENS J Formulation Revision 02/08/2008 片剂 甲状腺功能减退症 NDA # 021518 SOLIFENACIN SUCCINATE索非那辛 ASTELLAS Labeling Revision 02/08/2008 片剂 膀胱多动症 NDA # 021687 EZETIMIBE; SIMVASTATIN依泽替米贝/辛伐他汀 MSP SINGAPORE Labeling Revision 02/08/2008 片剂 降脂药 ANDA # 040613 HOMATROPINE METHYLBROMIDE/HYDROCODONE BITARTRATE重酒石酸二氢可待因酮/溴甲后马托品 HI TECH PHARMA Approval 02/08/2008 糖浆剂 麻醉药 NDA # 013055 ORPHENADRINE CITRATE枸橼酸奥芬那君 GRACEWAY Labeling Revision 02/11/2008 注射剂 麻醉药/解痉药 NDA # 020151 VENLAFAXINE HYDROCHLORIDE盐酸文拉法辛 WYETH PHARMS INC Labeling Revision 02/11/2008 胶囊（缓释） 抑郁症 ANDA # 065302 AZITHROMYCIN阿奇霉素 WOCKHARDT Approval 02/11/2008 片剂 抗生素 ANDA # 077491 PRAVASTATIN SODIUM普伐他汀钠 LEK PHARMS DD Approval 02/11/2008 片剂 降脂药 ANDA # 077821 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE无水萘磺酸右丙氧芬、对乙酰氨基酚 CONCORD LABS NJ Approval 02/11/2008 片剂 镇痛药 ANDA # 078371 FINASTERIDE非那雄胺 ACTAVIS TOTOWA Approval 02/11/2008 片剂 前列腺增生 ANDA # 078391 HYDROCHLOROTHIAZIDE氢氯噻嗪 CADISTA PHARMS Approval 02/11/2008 胶囊剂 利尿剂 ANDA # 078575 BICALUTAMIDE比卡鲁胺 SANDOZ Tentative Approval 02/11/2008 片剂 前列腺癌 ANDA # 078597 DIVALPROEX SODIUM双丙戊酸钠 SUN PHARM INDS LTD Tentative Approval 02/11/2008 片剂（DR） 抗癫痫药 NDA # 017892 TRIAZOLAM三唑仑 PHARMACIA AND UPJOHN Labeling Revision 02/12/2008 片剂 催眠剂 ANDA # 040717 PRIMIDONE扑米酮 IMPAX LABS Approval 02/12/2008 片剂 抗癫痫药 ANDA # 040724 PROMETHAZINE HYDROCHLORIDE盐酸异丙嗪 IMPAX LABS Approval 02/12/2008 片剂 抗过敏药 NDA # 020778 NELFINAVIR MESYLATE甲磺奈非那韦 AGOURON Labeling Revision 02/13/2008 粉末剂 抗艾滋药 NDA # 021336 SELEGILINE司来吉兰 SOMERSET Labeling Revision 02/13/2008 膜剂（ER） 帕金森症 ANDA # 078408 VINORELBINE TARTRATE 酒石酸长春瑞滨 EBEWE PHARMA Approval 02/13/2008 注射剂 抗肿瘤药 ANDA # 078678 GRANISETRON HYDROCHLORIDE盐酸格拉司琼 ORCHID HLTHCARE Approval 02/13/2008 片剂 化疗止吐药 NDA # 020683 ETHINYL ESTRADIOL; LEVONORGESTREL左炔诺孕酮/炔雌醇 WYETH PHARMS INC Labeling Revision 02/14/2008 片剂 避孕药 NDA # 022081 AMBRISENTAN安博森坦 GILEAD Labeling Revision 02/14/2008 片剂 肺动脉高压 ANDA # 040699 BENZTROPINE MESYLATE甲磺酸苯扎托品 ACTAVIS TOTOWA Approval 02/14/2008 片剂 帕金森症 ANDA # 078191 RAMIPRIL雷米普利 DR REDDYS LABS LTD Tentative Approval 02/14/2008 胶囊剂 高血压 ANDA # 078409 LAMOTRIGINE拉莫三嗪 SANDOZ Tentative Approval 02/14/2008 片剂 抗癫痫药 ANDA # 078692 CETIRIZINE HYDROCHLORIDE盐酸西替利嗪 SANDOZ Approval 02/14/2008 咀嚼片剂 抗过敏药 ANDA # 078922 ZIDOVUDINE齐多夫定 MATRIX LABS LTD Approval 02/14/2008 片剂 乙肝 NDA # 019962 METOPROLOL SUCCINATE琥珀酸美托洛尔 ASTRAZENECA Control Supplement 02/15/2008 片剂（ER） 高血压 NDA # 021277 MOXIFLOXACIN HYDROCHLORIDE盐酸莫西沙星 BAYER PHARMS Labeling Revision 02/15/2008 片剂 抗生素 NDA # 021085 MOXIFLOXACIN HYDROCHLORIDE盐酸莫西沙星 BAYER PHARMS Labeling Revision 02/15/2008 注射剂 抗生素 NDA # 021937 EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE依法韦仑/恩曲他滨/替诺福韦酯 GILEAD Labeling Revision 02/15/2008 片剂 抗艾滋药 NDA # 021985 ALISKIREN HEMIFUMARATE富马酸阿利克仑 NOVARTIS Labeling Revision 02/15/2008 片剂 高血压 NDA # 022078 NIACIN/SIMVASTATIN烟酸辛伐他汀 ABBOTT Approval 02/15/2008 片剂 降脂药 NDA # 050781 MINOCYCLINE HYDROCHLORIDE盐酸米诺环素 ORAPHARMA Labeling Revision 02/15/2008 粉剂（ER） 抗生素 ANDA # 065359 CEFUROXIME AXETIL头孢呋辛酯 ORCHID HLTHCARE Approval 02/15/2008 片剂 抗生素 ANDA # 078688 BENDROFLUMETHIAZIDE; NADOLOL苄氟噻嗪/纳多洛尔 MYLAN Approval 02/15/2008 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 BARR Approval 02/19/2008片剂/帕金森症 (NDA # 021548)FOSAMPRENAVIR CALCIUM福司安普那韦钙 GLAXOSMITHKLINE Labeling Revision 02/20/2008/片剂/抗艾滋药 (NDA # 021567)ATAZANAVIR SULFATE阿扎那韦硫酸盐 BRISTOL MYERS SQUIBB Labeling Revision 02/20/2008胶囊/抗艾滋药 (NDA # 021692) TRAMADOL HYDROCHLORIDE盐酸曲马多 BIOVAIL LABS INTL Labeling Revision 02/20/2008片剂（ER）/镇痛药 (NDA # 022029)METHYL SALICYATE/MENTHOL水杨酸甲酯/薄荷脑 HISAMITSU PHARM Approval 02/20/2008贴剂/止痛药 (ANDA # 077219)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 WATSON LABS Approval 02/20/2008注射剂/抗肿瘤药 (NDA # 016199) HYDROCORTISONE氢化可的松 ANI PHARMS Labeling Revision 02/21/2008灌肠剂/溃疡性结肠炎 |
2楼2008-04-03 16:23:40
xiaohezi7844
禁言 (知名作家)
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- 专业: 药物设计与药物信息
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(NDA # 018771)HYDROXYPROPYL CELLULOSE羟丙基纤维素 ATON Labeling Revision 02/21/2008眼部插入剂/干眼综合症 (NDA # 021036) ZANAMIVIR扎那米韦 GLAXOSMITHKLINE Labeling Revision 02/21/2008粉剂/抗病毒药 (NDA # 022028) COSYNTROPIN替可克肽 SANDOZ Approval 02/21/2008注射剂/促皮质素类药 (NDA # 050441) CLINDAMYCIN PHOSPHATE克林霉素磷酸酯 PHARMACIA AND UPJOHN Labeling Revision 02/21/2008/注射剂/抗生素 (NDA # 050536)ERYTHROMYCIN红霉素 HOSPIRA Labeling Revision 02/21/2008胶囊（DR）抗生素 (NDA # 050547)CEFOTAXIME SODIUM头孢噻肟钠 SANOFI AVENTIS US Labeling Revision 02/21/2008注射剂/抗生素 (ANDA # 065396)CEFADROXIL/CEFADROXIL HEMIHYDRATE头孢羟氨苄/半水头孢羟氨苄 LUPIN Approval 02/21/2008混悬剂/抗生素 (ANDA # 078024) CIPROFLOXACIN; DEXTROSE环丙沙星/葡萄糖 CLARIS LIFESCIENCES Tentative Approval 02/21/2008注射剂/抗生素 (BLA # 125057) ADALIMUMAB阿达木单抗 ABBOTT Supplement 02/21/2008注射剂/关节炎 (NDA # 021071) ROSIGLITAZONE MALEATE马来酸罗格列酮 SB PHARMCO Labeling Revision 02/22/2008片剂/降糖药 (NDA # 050794) AZACITIDINE阿扎胞苷 PHARMION Manufacturing Change or Addition 02/22/2008注射剂/骨髓增生异常综合征 (BLA # 125085)BEVACIZUMAB贝伐单抗 GENENTECH Supplement 02/22/2008注射剂/抗肿瘤药 (NDA # 018163) TEMAZEPAM替马西泮 TYCO HLTHCARE Labeling Revision 02/25/2008胶囊剂/催眠药 (NDA # 020895)SILDENAFIL CITRATE西地那非柠檬酸盐 PFIZER IRELAND Labeling Revision 02/25/2008片剂/抗ED药 (NDA # 021976) DARUNAVIR ETHANOLATE地瑞那韦 TIBOTEC Formulation Revision 02/25/2008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 PHARMS Approval 02/25/2008片剂（ER）过敏性鼻炎 (ANDA # 077234)AMIODARONE HYDROCHLORIDE盐酸胺碘酮 HIKMA FARMACEUTICA Approval 02/25/2008注射剂/抗心律失常药 (NDA # 021067) MOMETASONE FUROATE糠酸莫米松 SCHERING Labeling Revision 02/26/2008粉剂/皮质激素 (NDA # 021813)ESTRADIOL雌二醇 BRADLEY PHARMS Package Change 02/26/2008凝胶剂/雌激素 (NDA # 022044) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE磷酸西他列汀/盐酸二甲双胍 MERCK Efficacy Supplement with Clinical Data to Support 02/26/2008片剂/降糖药 (NDA # 022057) PROGESTERONE黄体酮 FERRING Labeling Revision 02/26/2008凝胶剂/孕激素 (ANDA # 040814)CARBINOXAMINE MALEATE马来酸卡比沙明 BOCA PHARMA Approval 02/26/2008口服溶液/抗过敏药 (NDA # 050609) ERYTHROMYCIN LACTOBIONATE乳糖酸红霉素 HOSPIRA Labeling Revision 02/26/2008注射剂/抗生素 (NDA # 050742) IVERMECTIN伊维菌素 MERCK Manufacturing Change or Addition 02/26/2008片剂/抗生素 (ANDA # 077728)CALCIUM ACETATE醋酸钙 ROXANE Approval 02/26/2008胶囊/营养补充剂 (ANDA # 078058)ANASTROZOLE阿那曲唑 TEVA PHARMS Tentative Approval 02/26/2008片剂/抗肿瘤药 (ANDA # 078098) TECHNETIUM TC-99M SESTAMIBI锝TC-99M司他比 MALLINCKRODT Tentative Approval 02/26/2008注射剂/诊断试剂 (ANDA # 078155) SIMVASTATIN辛伐他汀 ACCORD HLTHCARE Approval 02/26/2008片剂/降脂药 (ANDA # 078478)TORSEMIDE托拉塞米 SUN PHARM INDS Approval 02/26/2008片剂/利尿剂 (NDA # 021729) ARIPIPRAZOLE阿立哌唑 OTSUKA Patient Population Altered 02/27/2008注射剂/精神分裂症 (NDA # 022101)ESOMEPRAZOLE MAGNESIUM埃索美拉唑 ASTRAZENECA Approval 02/27/2008混悬剂/ppi (ANDA # 040797) MEPROBAMATE甲丙氨酯 INVAGEN PHARMS Approval 02/27/2008片剂/抗焦虑药 (NDA # 050317) LINCOMYCIN HYDROCHLORIDE盐酸林可霉素 PHARMACIA AND UPJOHN Labeling Revision 02/27/2008注射剂/抗生素 (NDA # 050435) CARBENICILLIN INDANYL SODIUM苄茚西林钠 PFIZER Labeling Revision 02/27/2008片剂/抗生素 (ANDA # 065425)DEMECLOCYCLINE HYDROCHLORIDE盐酸去甲金霉素 AMNEAL PHARM Approval 02/27/2008片剂/抗生素 (ANDA # 077260)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 TEVA PARENTERAL Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 077776)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 APP PHARMS Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 077994)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 SANDOZ Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 078037) GRANISETRON HYDROCHLORIDE盐酸格拉司琼 CIPLA LIMITED Approval 02/27/2008片剂/抗肿瘤药 (ANDA # 078188) IRINOTECAN HYDROCHLORIDE盐酸伊立替康 DABUR ONCOLOGY PLC Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 078224) AMLODIPINE BESYLATE苯磺酸氨氯地平 MATRIX LABS Approval 02/27/2008片剂/高血压 (ANDA # 078589)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 ACTAVIS TOTOWA Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 078745)RAMIPRIL雷米普利 INVAGEN PHARMS Tentative Approval 02/27/2008胶囊/高血压 (ANDA # 078796)IRINOTECAN HYDROCHLORIDE盐酸伊立替康 HOSPIRA Approval 02/27/2008注射剂/抗肿瘤药 (ANDA # 078843)GRANISETRON HYDROCHLORIDE盐酸格拉司琼 APOTEX INC Approval 02/27/2008片剂/止吐药 (NDA # 019872) ACETAMINOPHEN对乙酰氨基酚 MCNEIL CONS Labeling Revision 02/28/2008片剂（ER）解热镇痛药 (NDA # 021318) TERIPARATIDE RECOMBINANT HUMAN人重组特立帕肽 LILLY Labeling Revision 02/28/2008注射剂/骨质疏松 (NDA # 021688) CINACALCET HYDROCHLORIDE盐酸西那卡塞 AMGEN Labeling Revision 02/28/2008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 GILEAD Labeling Revision 02/28/2008片剂/抗艾滋药 (NDA # 022033) FLUVOXAMINE MALEATE马来酸氟伏沙明 SOLVAY PHARMS Approval 02/28/2008片剂（ER）/抗抑郁药 (ANDA # 040751) IMIPRAMINE HYDROCHLORIDE盐酸丙咪嗪 ACTAVIS TOTOWA Approval 02/28/2008片剂/抗抑郁药 (ANDA # 078334) GRANISETRON HYDROCHLORIDE盐酸格拉司琼 CYPRESS PHARM Approval 02/28/2008口服溶液/止吐药 (ANDA # 078957) STAVUDINE司他夫定 INVAGEN PHARMS Tentative Approval 02/28/2008胶囊/抗艾滋药 (NDA # 010402)ESTROGENS, CONJUGATED共轭雌激素 WYETH PHARMS INC Labeling Revision 02/29/2008注射剂/雌激素缺乏症 (NDA # 020591) TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE群多普利/维拉帕米 ABBOTT Labeling Revision 02/29/2008片剂（ER）/高血压 (NDA # 021229)OMEPRAZOLE MAGNESIUM奥美拉唑镁 ASTRAZENECA Package Change 02/29/2008片剂（DR）/PPI (NDA # 021305) SODIUM IODIDE, I-131碘化钠 DRAXIMAGE Labeling Revision 02/29/2008胶囊/诊断试剂 (NDA # 021348) MIGLUSTAT美格鲁特 ACTELION PHARMS Labeling Revision 02/29/2008胶囊/Gaucher病 (NDA # 021372) PALONOSETRON HYDROCHLORIDE盐酸帕洛诺司琼 HELSINN HLTHCARE Efficacy Supplement with Clinical Data to Support 02/29/2008注射剂/止吐药 (NDA # 021610) OXYMORPHONE HYDROCHLORIDE盐酸羟吗啡酮 ENDO PHARMS Manufacturing Change or Addition 02/29/2008片剂（ER）/镇痛药 （NDA # 021992) DESVENLAFAXINE SUCCINATE琥珀酸去甲文拉法辛 WYETH PHARMS INC Approval 02/29/2008片剂（ER）/抗抑郁症 (NDA # 022118)FENOFIBRATE非诺贝特 LIFECYCLE PHARMA AS Labeling Revision 02/29/2008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 LABS Tentative Approval 02/29/2008胶囊/高血压 (ANDA # 078566) GRANISETRON HYDROCHLORIDE盐酸格拉斯琼 WOCKHARDT USA Approval 02/29/2008注射剂/止吐药 (ANDA # 078886) EFAVIRENZ依法韦恩茨 INVAGEN PHARMS Tentative Approval 02/29/2008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 HLTHCARE Labeling Revision 03/01/2008/注射剂/抗生素 (NDA # 004782) ESTROGENS, CONJUGATED共轭雌激素 WYETH PHARMS INC Labeling Revision 03/03/2008/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 INC Labeling Revision 03/03/2008/片剂/雌激素缺乏症 (NDA # 021008) OCTREOTIDE ACETATE醋酸奥曲肽 NOVARTIS New or Modified Indication 03/03/2008/注射剂/肢端肥大症/抗肿瘤药 （ANDA # 078313) ESCITALOPRAM OXALATE草酸s-西酞普兰 WATSON LABS Tentative Approval 03/03/2008/片剂/抑郁症 (ANDA # 078639) FOMEPIZOLE甲吡唑 SYNERX PHARMA Approval 03/03/2008/注射剂/解毒剂 (ANDA # 078710) TELMISARTAN替米沙坦 WATSON LABS Tentative Approval 03/03/2008/片剂/高血压 (NDA # 021779) ILOPROST依诺前列环素 ACTELION PHARM Labeling Revision 03/04/2008/溶液剂/肺动脉高压 (ANDA # 077329) OCTREOTIDE ACETATE醋酸奥曲肽 SUN PHARM INDS Approval 03/04/2008/注射剂/肢端肥大症/抗肿瘤药 (ANDA # 077982) ALENDRONATE SODIUM阿仑膦酸钠 APOTEX Tentative Approval 03/04/2008/片剂/骨质疏松 (ANDA # 078433) GEMCITABINE HYDROCHLORID盐酸E吉西他宾 SUN PHARM INDS Tentative Approval 03/04/2008注射剂/抗肿瘤 (NDA # 021083) SIROLIMUS西罗莫司 WYETH PHARMS INC Labeling Revision 03/05/2008/口服溶液/免疫抑制剂 (NDA # 021548) FOSAMPRENAVIR CALCIUM福沙那韦钙 GLAXOSMITHKLINE Labeling Revision 03/05/2008/片剂/抗AIDS (NDA # 022116) FOSAMPRENAVIR CALCIUM福沙那韦钙 GLAXO Labeling Revision 03/05/2008/混悬液/抗AIDS (ANDA # 040673) PROMETHAZINE HYDROCHLORIDE盐酸异丙嗪 ACTAVIS TOTOWA Approval 03/05/2008/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 PHARMA Tentative Approval 03/05/2008/片剂/降压药 (NDA # 015034) MEFENAMIC ACID甲芬那酸 SCIELE PHARMA INC Labeling Revision 03/06/2008/胶囊/NSAIDs (NDA # 020990) SERTRALINE HYDROCHLORIDE盐酸舍曲林 PFIZER Labeling Revision 03/06/2008/片剂/抑郁症 (NDA # 021299) PAROXETINE MESYLATE甲磺酸帕罗西汀 JDS PHARMS Labeling Revision 03/06/2008/片剂/抑郁症 (NDA # 021436) ARIPIPRAZOLE阿立派唑 OTSUKA Labeling Revision 03/06/2008/片剂/精神分裂症 (ANDA # 078537) FOMEPIZOLE甲吡唑 NAVINTA LLC Approval 03/06/2008/注射剂/解毒剂 (NDA # 020140) LEVOLEUCOVORIN左亚叶酸 SPECTRUM PHARMS Approval 03/07/2008/注射剂/抗肿瘤 (NDA # 020829) MONTELUKAST SODIUM孟鲁司特钠 MERCK Labeling Revision 03/07/2008/片剂/抗哮喘药 (NDA # 021976) DARUNAVIR ETHANOLATE地瑞那韦 TIBOTEC Labeling Revision 03/07/2008/片剂/抗AIDS (ANDA # 078465) PREDNISOLONE SODIUM PHOSPHATE泼尼松龙磷酸钠 PHARM ASSOC Approval 03/07/2008/溶液剂/抗炎药 (ANDA # 078671) NABUMETONE萘丁美酮 INVAGEN PHARMS Approval 03/07/2008/片剂/NSAIDs (BLA # 103234) EPOETIN ALFA阿法依泊汀 AMGEN Supplement 03/07/2008/注射剂/贫血 (BLA # 103951) DARBEPOETIN ALFA阿法达贝泊汀 AMGEN Supplement 03/07/2008/注射剂/贫血 (NDA # 018936) FLUOXETINE HYDROCHLORIDE盐酸氟西汀 LILLY Labeling Revision 03/09/2008/胶囊剂/抑郁症 (NDA # 020675) URSODIOL熊去氧胆酸 AXCAN SCANDIPHARM Package Change 03/10/2008/片剂/胆结石 (NDA # 021266) VORICONAZOLE伏立康唑 PFIZER Labeling Revision 03/10/2008/混悬剂/抗菌药 (ANDA # 077763) CLOBETASOL PROPIONATE二丙酸氯倍他米松 PERRIGO ISRAEL Approval 03/10/2008/喷雾剂/抗炎药 (ANDA # 078695) ROSIGLITAZONE MALEATE马来酸罗格列酮 ROXANE Tentative Approval 03/10/2008/片剂/降糖药 (NDA # 016151) METHENAMINE HIPPURATE马尿酸乌洛托品 VATRING PHARMS Labeling Revision 03/11/2008/片剂/抗菌药 (NDA # 018452) SULFAMETHOXAZOLE; TRIMETHOPRIM磺胺甲基异恶唑 MONARCH PHARMS Labeling Revision 03/11/2008/注射剂/抗生素 (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 INC Labeling Revision 03/11/2008/混悬剂ER/抗感冒药(NDA # 050717) FOSFOMYCIN TROMETHAMINE磷霉素缓血酸胺 ZAMBON Labeling Revision 03/11/2008/混悬剂/抗菌药 (ANDA # 065407) TOBRAMYCIN SULFATE硫酸妥布霉素 AKORN STRIDES Approval 03/11/2008/注射剂/抗生素 (ANDA # 065470) MINOCYCLINE HYDROCHLORIDE盐酸米诺环素 AUROBINDO PHARMA Approval 03/11/2008/胶囊/抗生素 (NDA # 017111) MOLINDONE HYDROCHLORIDE盐酸吗茚酮 ENDO PHARMS Labeling Revision 03/12/2008/胶囊/精神分裂症 (NDA # 020444) EPOPROSTENOL SODIUM依前列醇钠 GLAXOSMITHKLINE Labeling Revision 03/12/2008/注射剂/肺动脉高压 (ANDA # 040812) HYDROXYZINE羟嗪 INVAGEN PHARMS Approval 03/12/2008/片剂/抗焦虑药 (ANDA # 075982) TRAMADOL HYDROCHLORIDE盐酸曲马多 PLIVA Control Supplement 03/12/2008/片剂/镇痛药 (ANDA # 077413) PACLITAXEL紫杉醇 PLIVA LACHEMA Approval 03/12/2008/注射剂/抗肿瘤药 (ANDA # 077455) BUPROPION HYDROCHLORIDE盐酸安非他酮 ACTAVIS Approval 03/12/2008/片剂ER/抗抑郁药 (NDA # 018117) TRIAMCINOLONE ACETONIDE醋酸曲安奈德 ABBOTT Labeling Revision 03/13/2008/喷雾剂/抗炎药 (NDA # 022047) QUETIAPINE FUMARATE富马酸喹硫平 ASTRAZENECA Manufacturing Change or Addition 03/13/2008/片剂ER/精神分裂症 (NDA # 050706) MEROPENEM美罗培南 ASTRAZENECA Labeling Revision 03/13/2008/注射剂/抗生素 (ANDA # 078564) GRANISETRON HYDROCHLORIDE盐酸格拉司琼 WOCKHARDT Tentative Approval 03/13/2008/注射剂/止吐药 (ANDA # 078902) PAROXETINE HYDROCHLORIDE盐酸帕罗西汀 MYLAN Approval 03/13/2008/片剂/抗抑郁药 (NDA # 020986) INSULIN ASPART RECOMBINANT重组胰岛素 NOVO NORDISK INC Patient Population Altered 03/14/2008/注射剂/降糖药(NDA # 021794) DAPSONE氨苯砜 QLT USA Efficacy Supplement with Clinical Data to Support 03/14/2008/凝胶剂/寻常痤疮 (ANDA # 077126) AMIFOSTINE阿米福汀 SUN PHARM INDS Approval 03/14/2008/注射剂/抗肿瘤 |
3楼2008-04-03 16:24:00
xiaohezi7844
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FDA08年三月批准的药品（下） ************************* (NDA # 020409) FLUNISOLIDE氟尼松 IVAX RES LLC Manufacturing Change or Addition 03/17/2008/喷雾剂/肾上腺皮质激素 (NDA # 022207) MORPHINE SULFATE硫酸吗啡 ROXANE Approval 03/17/2008/片剂/镇痛药 (ANDA # 040723) ISOSORBIDE DINITRATE硝酸异山梨酯 COREPHARMA Approval 03/17/2008/片剂（ER）/心绞痛 (ANDA # 076128) OFLOXACIN氧氟沙星 BAUSCH AND LOMB Approval 03/17/2008/滴剂/抗生素 (ANDA # 076616) OFLOXACIN氧氟沙星 HI TECH PHARMA Approval 03/17/2008/滴剂/抗生素 (ANDA # 078222) OFLOXACIN氧氟沙星 ALCON Approval 03/17/2008/滴剂/抗生素 (ANDA # 078308) ONDANSETRON HYDROCHLORIDE盐酸昂丹司琼 CLARIS LIFESCIENCES Approval 03/17/2008/注射剂/止吐药 (ANDA # 077138) CIPROFLOXACIN环丙沙星 TEVA PARENTERAL Approval 03/18/2008/注射剂/抗生素 (ANDA # 077753) CIPROFLOXACIN环丙沙星 HOSPIRA Approval 03/18/2008/注射剂/抗生素 (ANDA # 077888) CIPROFLOXACIN环丙沙星 BAXTER HLTHCARE Approval 03/18/2008/注射剂/抗生素 (ANDA # 078024) CIPROFLOXACIN环丙沙星 CLARIS LIFESCIENCES Approval 03/18/2008/注射剂/抗生素 (ANDA # 078114) CIPROFLOXACIN环丙沙星 BEDFORD Approval 03/18/2008/注射剂/抗生素 (ANDA # 078173) RIZATRIPTAN BENZOATE苯甲酸利扎曲坦 MYLAN PHARMA Tentative Approval 03/18/2008/口崩片/偏头痛 (ANDA # 078252) CIPROFLOXACIN环丙沙星 ACS DOBFAR INFO SA Approval 03/18/2008/注射剂/抗生素 (ANDA # 078476) FOSPHENYTOIN SODIUM磷苯妥英钠 AKORN STRIDES Approval 03/18/2008/注射剂/抗癫痫药 (NDA # 021400) VARDENAFIL HYDROCHLORIDE盐酸伐地那非 BAYER HLTHCARE Labeling Revision 03/19/2008/片剂/抗ED药 (ANDA # 040587) BENZONATATE苯佐那酯 SUN PHARM INDS INC Approval 03/19/2008/胶囊/镇咳药 (ANDA # 065441) CEFEPIME HYDROCHLORIDE盐酸头孢吡肟 ACS DOBFAR Approval 03/19/2008/注射剂/抗生素 (ANDA # 077100) DIVALPROEX SODIUM双丙戊酸钠 ZYDUS PHARMS USA Tentative Approval 03/19/2008/片剂（DR）/抗癫痫药 (NDA # 020692) SALMETEROL XINAFOATE沙美特罗羟萘甲酸盐 GLAXO GRP LTD Labeling Revision 03/20/2008/粉剂/平喘药 (NDA # 021223) ZOLEDRONIC ACID唑来膦酸 NOVARTIS Patient Population Altered 03/20/2008/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 GLAXOSMITHKLINE Labeling Revision 03/20/2008/喷雾剂/平喘药 (NDA # 022056) OMEPRAZOLE/奥美拉唑 ASTRAZENECA Approval 03/20/2008/混悬剂/PPI (NDA # 022177) STAVUDINE; LAMIVUDINE; NEVIRAPINE司他夫定/拉米夫定/奈韦拉平 STRIDES ACROLAB Tentative Approval 03/20/2008/片剂/抗艾滋药(NDA # 022249) BENDAMUSTINE HYDROCHLORIDE盐酸苯达莫司汀 CEPHALON Approval 03/20/2008/注射剂/白血病 (ANDA # 040418) ACETAMINOPHEN; HYDROCODONE BITARTRATE对乙酰氨基酚，重酒石酸氢可酮 MALLINCKRODT Control Supplement 03/20/2008/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 LABS Package Change 03/20/2008/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 Addition 03/20/2008/片剂/镇痛药 (ANDA # 076642) HYDROCODONE BITARTRATE; IBUPROFEN重酒石酸氢可酮，布洛芬 INTERPHARM Packager Addition 03/20/2008/片剂/镇痛药 (ANDA # 076899) SULFAMETHOXAZOLE; TRIMETHOPRIM磺胺甲恶唑-甲氧苄啶 INTERPHARM Packager Addition 03/20/2008/片剂/抗生素 (ANDA # 077094) RIBAVIRIN利巴韦林 ZYDUS PHARMS USA Packaging Addition 03/20/2008/片剂/抗病毒药 (ANDA # 077289) CITALOPRAM HYDROBROMIDE氢溴酸西酞普兰 INTERPHARM Packager Addition 03/20/2008/片剂/抗抑郁药 (ANDA # 077743) RIBAVIRIN利巴韦林 SANDOZ Control Supplement 03/20/2008/片剂/抗病毒药 (ANDA # 077779) METOPROLOL SUCCINATE酒石酸美托洛尔 KV PHARM Approval 03/20/2008/片剂（ER）/降压药 (ANDA # 077824) RANITIDINE HYDROCHLORIDE盐酸雷尼替丁 INTERPHARM Packager Addition 03/20/2008/片剂/H2受体拮抗剂 (ANDA # 077880) METFORMIN HYDROCHLORIDE盐酸二甲双胍 INTERPHARM Packager Addition 03/20/2008/片剂/降糖药 (ANDA # 078149) ASPIRIN; BUTALBITAL; CAFFEINE阿司匹林/布他比妥/咖啡因 MUTUAL PHARM Facility Addition 03/20/2008/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 Revision 03/20/2008/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 PHARMS Labeling Revision 03/21/2008/胶囊/镇痛药 (NDA # 021235) FLUOXETINE HYDROCHLORIDE盐酸氟西汀 LILLY Labeling Revision 03/21/2008/口服溶液/抗抑郁药 (NDA # 021520) FLUOXETINE HYDROCHLORIDE; OLANZAPINE盐酸氟西汀；奥氮平 LILLY Labeling Revision 03/21/2008/胶囊/抗抑郁药 (ANDA # 040847) GLYCOPYRROLATE格隆溴胺 INDICUS PHARMA Approval 03/21/2008/片剂/抗胆碱药 (ANDA # 040875) PHENTERMINE HYDROCHLORIDE盐酸苯丁胺 KVK TECH Approval 03/21/2008/胶囊/食欲抑制剂 (ANDA # 078014) ONDANSETRON HYDROCHLORIDE盐酸昂丹司琼 TARO PHARMS IRELAND Approval 03/21/2008/注射剂/止吐药 (ANDA # 078926) GABAPENTIN加巴喷丁 ZYDUS PHARMS USA INC Tentative Approval 03/21/2008/片剂/抗癫痫药 (NDA # 017531) TRIMETHOBENZAMIDE HYDROCHLORIDE盐酸三甲氧苯酰胺 KING PHARMS Labeling Revision 03/24/2008/胶囊/术后恶心呕吐 (NDA # 021168) DIVALPROEX SODIUM双丙戊酸钠 ABBOTT Patient Population Altered 03/24/2008/片剂（ER）/抗癫痫药 (NDA # 021337) ERTAPENEM SODIUM厄他培南钠 MERCK Labeling Revision 03/24/2008/注射剂/抗生素 (NDA # 021777) CYCLOBENZAPRINE HYDROCHLORIDE盐酸环苯扎林 ANESTA Labeling Revision 03/24/2008/胶囊（ER）/肌松药 (NDA # 022267) DIVALPROEX SODIUM双丙戊酸钠 ABBOTT Approval 03/24/2008/片剂（ER）/抗癫痫药 (NDA # 021567) ATAZANAVIR SULFATE硫酸阿扎那韦 BRISTOL MYERS SQUIBB Patient Population Altered 03/25/2008/胶囊/抗艾滋药 (BLA # 125019) IBRITUMOMAB TIUXETAN伊莫单抗 IDEC PHARMACEUTICALS CORP Supplement 03/25/2008/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 Approval 03/26/2008/片剂/抗生素 (ANDA # 076509) FENOFIBRATE非诺贝特 IMPAX LABS Approval 03/26/2008/片剂/降脂药 (ANDA # 040704) BETHANECHOL CHLORIDE氯贝丁酯 LANNETT Approval 03/27/2008/片剂/降脂药 (NDA # 050706) MEROPENEM美罗培南 ASTRAZENECA Labeling Revision 03/27/2008/注射剂/抗生素 (NDA # 050726) AMOXICILLIN; CLAVULANATE POTASSIUM阿莫西林/克拉维酸钾 GLAXOSMITHKLINE Labeling Revision 03/27/2008注射剂/抗生素/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 MERCK Labeling Revision 03/28/2008咀嚼片/抗生素/β-内酰胺类/β-内酰胺酶抑制剂 (NDA # 050761) AMOXICILLIN阿莫西林 GLAXOSMITHKLINE Labeling Revision 03/28/2008/咀嚼片/抗生素 (ANDA # 065390) RIFAMPIN利福平 LANNETT Approval 03/28/2008/胶囊/抗生素 (ANDA # 078525) LAMOTRIGINE拉莫三嗪 TARO PHARM INDS Tentative Approval 03/28/2008/片剂/抗癫痫药 (NDA # 021319) DUTASTERIDE度他雄胺 GLAXOSMITHKLINE Labeling Revision 03/31/2008/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 USA Approval 03/31/2008/乳膏OTC/防晒剂 (NDA # 022064) LEVOCETIRIZINE DIHYDROCHLORIDE盐酸左旋西替利嗪 UCB INC Labeling Revision 03/31/2008/片剂/H1受体拮抗剂 (ANDA # 040842) HYDROXYZINE HYDROCHLORIDE盐酸羟吗啡酮 NORTHSTAR HLTHCARE Approval 03/31/2008/片剂/镇痛药 (ANDA # 078084) METRONIDAZOLE甲硝唑 CLARIS LIFESCIENCES Approval 03/31/2008/注射剂/抗厌氧菌与抗滴虫药 (ANDA # 040876) PHENTERMINE HYDROCHLORIDE盐酸苯丁胺 NORTHSTAR HLTHCARE Approval 03/31/2008/片剂/食欲抑制剂 (NDA # 020090) FLUCONAZOLE氟康唑 PFIZER Labeling Revision 03/31/2008/口服混悬剂/抗真菌药 |
4楼2008-04-03 16:24:30
jiaruohuang
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5楼2008-04-03 21:32:16