List of Reference Preparations for Generic Drugs (13th & 14th batch) |
List of Reference Preparations for Generic Drugs (13th batch) |
No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note 1 | Note 2 |
13-1 | 苯磺贝他斯汀片 | Bepotastine Besilate Tablets/TALION | 10mg | Tablet | Mitsubishi Tanabe Pharma Corporation | Original Import |
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13-2 | 卡格列净片 | CanagliflozinTablets/INVOKANA | 100mg | Tablet | Janssen-Cilag International NV | Original Import |
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13-3 | 卡格列净片 | CanagliflozinTablets/INVOKANA | 300mg | Tablet | Janssen-Cilag International NV | Original Import |
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13-4 | 安立生坦片 | Ambrisentan Tablets /VOLIBRIS | 5mg | Tablet | GLAXOSMITHKLINE INC. | Original Import |
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13-5 | 安立生坦片 | Ambrisentan Tablets /VOLIBRIS | 10mg | Tablet | GLAXOSMITHKLINE INC. | Original Import |
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13-6 | 门冬氨酸钾镁片 | Potassium Aspartate and Magnesium Aspartate Tablets/Panangin | Magnesium Aspartate 0.140g & Potassium Aspartate 0.158g | Tablet | Gedeon Richter Plc. | Original Import |
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13-7 | 琥珀酸普芦卡必利片 | PrucaloprideSuccinate Tablets / Resolor | 1mg | Tablet | Janssen Inc. | Original Import |
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13-8 | 琥珀酸普芦卡必利片 | PrucaloprideSuccinate Tablets / Resolor | 2mg | Tablet | Janssen Inc. | Original Import |
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13-9 | 替格瑞洛片 | Ticagrelor Tablets / BRILINTA | 60mg | Tablet | AstraZeneca AB | Original Import |
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13-10 | 马来酸阿法替尼片 | Afatinib Dimaleate Tablets/GIOTRIF | 20mg | Tablet | Boehringer Ingelheim International GmbH | Original Import |
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13-11 | 马来酸阿法替尼片 | Afatinib Dimaleate Tablets/GIOTRIF | 30mg | Tablet | Boehringer Ingelheim International GmbH | Original Import |
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13-12 | 马来酸阿法替尼片 | Afatinib Dimaleate Tablets/GIOTRIF | 40mg | Tablet | Boehringer Ingelheim International GmbH | Original Import |
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13-13 | 马来酸阿法替尼片 | Afatinib Dimaleate Tablets/GIOTRIF | 50mg | Tablet | Boehringer Ingelheim International GmbH | Original Import |
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13-14 | 盐酸倍他司汀片 | Betahistine Dihydrochloride Tablets/SERC | 8mg | Tablet | MYLAN MEDICAL SAS | EU-listed (Origin: France) |
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13-15 | 枸橼酸氢钾钠颗粒 | Potassium Sodium Hydrogen Citrate Granules/Uralyt-U | 97.1g/100g | Granules | Madaus GmbH | Original Import |
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13-16 | 加巴喷丁capsule | Gabapentin Capsules/Neurontin | 100mg | Capsule | Pfizer Pharma Pfe GmbH | EU-listed (Origin: Germany) |
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13-17 | 加巴喷丁capsule | Gabapentin Capsules/Neurontin | 300mg | Capsule | Pfizer Pharma Pfe GmbH | EU-listed |
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(Origin: Germany) |
13-18 | 加巴喷丁capsule | Gabapentin Capsules/Neurontin | 400mg | Capsule | Pfizer Pharma Pfe GmbH | EU-listed |
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(Origin: Germany) |
13-19 | 盐酸莫西沙星片 | MoxifloxacinHydrochloride Tablets/Avelox | 400mg | Tablet | Bayer Vital GmbH | Original Import |
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13-20 | 贝前列素钠片 | Beraprost Sodium Tablets/Dorner | 20μg | Tablet | Toray Industries, Inc. | Original Import |
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13-21 | 吡拉西坦颗粒 | Piracetam Granules/Nootropil | 2400mg | Granules | UCB Magyarország Kft. | EU-listed (Origin: Belgium) |
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13-22 | 氨苄西林capsule | Ampicillin Capsules/AMPICILLIN TRIHYDRATE | 250mg(on C16H19N3O4S base) | Capsule | DAVA Pharmaceuticals INC | Orange Book-USA |
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13-23 | 瑞格列奈二甲双胍片 | Repaglinide and Metformin Hydrochloride Tablets/-- | 1mg/500mg | Tablet | LUPIN LTD | Orange Book-USA |
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13-24 | 瑞格列奈二甲双胍片 | Repaglinide and Metformin Hydrochloride Tablets/-- | 2mg/500mg | Tablet | LUPIN LTD | Orange Book-USA |
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13-25 | 复方甘草酸苷片 | Compound Glycyrrhizin Tablets/Stronger Neo-MinophagenC(美能) | Glycyrrhizic acid monoammonium salt 35mg (glycyrrhizin 25mg), glycine 25mg, DL Methionine 25mg | Tablet | MinophagenPharmaceutical Co., Ltd. | Original Import |
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13-26 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 5mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-27 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 10mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-28 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 15mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-29 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 20mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-30 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 30mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-31 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 40mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-32 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 60mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-33 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 80mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-34 | 盐酸羟考酮缓释片 | Oxycodone Hydrochloride Prolonged-release Tablets/OXYCONTIN | 120mg | Tablet | NAPP PHARMACEUTICALS LIMITED | Original Import |
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13-35 | 盐酸丙卡特罗颗粒 | Procaterol Hydrochloride Granules/Meptin | 0.01% 1g (1g:100μg) | Granules | OTSUKA PHARMACEUTICAL Co.,Ltd. | Orange Book-Japan |
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13-36 | 缬沙坦 | Valsartan Capsules | 80mg | capsule | Beijing Novartis Pharma Ltd | Produced in China by original enterprises |
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13-37 | 缬沙坦 | Valsartan Capsules | 160mg | capsule | Beijing Novartis Pharma Ltd | Produced in China by original enterprises |
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13-38 | 氟伐他汀钠缓释片 | Fluvastatin Sodium extended release tablets | 80mg | Tablet | Beijing Novartis Pharma Ltd | Produced in China by original enterprises |
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13-39 | 替比夫定片 | Telbivudine Tablets | 600mg | Tablet | Beijing Novartis Pharma Ltd | Produced in China by original enterprises |
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13-40 | 赛洛多辛 | Silodosin Capsules | 4mg | capsule | Daiichi Sankyo Pharmaceutical (Beijing) Co. LTD | Produced in China by original enterprises |
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13-41 | 硫酸特布他林片 | Terbutaline Sulphate Tablets | 2.5mg | Tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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13-42 | 单硝酸异山梨酯缓释片 | Isosorbide Mononitrate Sustained Release Tablets | 30mg | Tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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13-43 | 单硝酸异山梨酯缓释片 | Isosorbide Mononitrate Sustained Release Tablets | 60mg | Tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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13-44 | 兰索拉唑肠溶capsule | Lansoprazole Enteric-coated Capsules | 30mg | capsule | Tianjin Takeda Pharmaceuticals co., ltd | Produced in China by original enterprises |
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13-45 | 托吡酯片 | Topiramate Tablets | 25mg | Tablet | Xian-Janssen Pharmaceutical Ltd | Produced in China by original enterprises |
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13-46 | 托吡酯片 | Topiramate Tablets | 100mg | Tablet | Xian-Janssen Pharmaceutical Ltd | Produced in China by original enterprises |
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13-47 | 伊曲康唑capsule | Itraconazole Capsules | 0.1g | capsule | Xian-Janssen Pharmaceutical Ltd | Produced in China by original enterprises |
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13-48 | 氟哌噻吨美利曲辛片 | Flupentixol and Melitracen Tablets/Deanxit | Flupentixol 0.5mg,Melitracen 10mg | film-coated tablets | H.Lundbeck N.V. | EU-listed( listed country:Belgium,Origin:Denmark) | supplement |
13-49 | 乙酰半胱氨酸颗粒 | Acetylcysteine Granules/ | 0.2g | Granules | ZAMBON ITALIA S.R.L | listed country:Italy,Origin:Italy | supplement |
Fluimucil |
13-50 | 格列喹酮片 | Gliquidone Tablets/Glurenorm | 30mg | Tablet | Astellas Pharma GmbH/Glenwood GmbH PharmazeutischeErzeugnisse | EU-listed( listed country:Germany;Origin:Greece) | supplement |
10-214 | 氨氯地平阿托伐他汀钙片 | Amlodipine Besylate and Atorvastatin Calcium Tablets/-- | Amlodipine Besylate 5mg,Atorvastatin Calcium 10mg | Tablet | Pfizer Prism CV | Original Import | Applicant Holder Corrected from “Pfizer Prism CV”to “PF Prism CV” |
10-215 | 氨氯地平阿托伐他汀钙片 | Amlodipine Besylate and Atorvastatin Calcium Tablets/-- | Amlodipine Besylate 5mg,Atorvastatin Calcium 20mg | Tablet | Pfizer Prism CV | Original Import | Applicant Holder Corrected from “Pfizer Prism CV”to “PF Prism CV” |
10-216 | 氨氯地平阿托伐他汀钙片 | Amlodipine Besylate and Atorvastatin Calcium Tablets/-- | Amlodipine Besylate 5mg,Atorvastatin Calcium 40mg | Tablet | Pfizer Prism CV | Original Import | Applicant Holder Corrected from “Pfizer Prism CV”to “PF Prism CV” |