List of Reference Preparations for Generic Drugs (15th & 16th batch) |
List of Reference Preparations for Generic Drugs (15th batch) |
No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note 1 | Note 2 |
15-1 | 盐酸司来吉兰片 | Selegiline Hydrochloride Tablets | 5mg | Tablet | Orion Corporation | original import |
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15-2 | 酮咯酸氨丁三醇片 | Ketorolac Tromethamine Tablets | 10mg | Tablet | MYLAN PHARMACEUTICALS INC | Orange Book-USA |
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15-3 | 布南色林片 | BlonanserinTablets | 4mg | Tablet(dispersed tablets) | Laboratoire GlaxoSmithKline | EU-ListedListed Country: France, Origin: France |
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15-4 | 阿莫西林分散片 | Amoxicillin Dispersible Tablets/Clamoxyl | 1g | Tablet | GLAXOSMITHKLINE INC. | original import |
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15-5 | 格列齐特片 | Gliclazide Tablets/Diaprel | 80mg | Tablet | Les Laboratoires Servier | Estonia-Listed( Origin: France Or Ireland) |
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15-6 | 头孢拉定胶囊 | Cefradine 250mg Capsules | 0.25g | Capsule | Sino - American Shanghai Squibb Pharmaceutical Co. LTD | Produced in China by original enterprises |
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15-7 | 盐酸坦索罗辛 | Tamsulosin Hydrochloride Sustained-release Capsules | 1g | Capsule (sustained release capsules) | Astellas Pharmaceutical (China) Co. LTD | Produced in China by original enterprises |
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15-8 | 克拉霉素缓释片 | Clarithromycin Sustained-release Tablets/Biaxin XL | 0.5g | Tablet | Mylan Healthcare Ca | Listed country: Canada | supplement |
15-9 | 氟氯西林钠颗粒 | Flucloxacillin Sodium Granules/-- | 0.125g/5ml(On the C19H17ClFN3O5S basis) | Granules | Accord Healthcare Ltd | EU-Listed(Listed country: UK;Origin: Ireland) | supplement |
15-10 | 奥美沙坦酯氢氯噻嗪片 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | Olmesartan Medoxomil:20mg & Hydrochlorothiazide 12.5mg | Tablet | Daiichi Sankyo Pharmaceutical (Shanghai) Co., LTD | Produced in China by original enterprises |
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List of Reference Preparations for Generic Drugs (16th batch) |
No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note 1 | Note 2 |
1月16日 | 青霉素V钾片 | Phenoxymethylpenicillin Potassium Tablets/-- | 0.25g | Tablet | Sandoz GmbH | Internationally recognized import |
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2月16日 | 阿奇霉素干混悬剂 | Azithromycin for Suspension/Sumamed | 200mg/5ml | Oral suspension (dry suspension) | Pliva Croatia Ltd. | original import |
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3月16日 | 甲磺酸溴隐亭片 | Bromocriptine Mesilate Tablets/Parlodel | 2.5mg | Tablet | Future Health Pharma GmbH | original import |
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4月16日 | 他达拉非片 | Tadalafil Tablets/CIALIS | 20mg | Tablet | Eli Lilly Nederland B.V. | original import |
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5月16日 | 他达拉非片 | Tadalafil Tablets/CIALIS | 10mg | Tablet | Eli Lilly Nederland B.V. | original import |
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6月16日 | 他达拉非片 | Tadalafil Tablets/CIALIS | 2.5mg | Tablet | Eli Lilly Nederland B.V. | original import |
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7月16日 | 阿瑞匹坦胶囊 | Aprepitant Capsules/意美 | 80mg | Capsule | Merck Sharp & Dohme Ltd. | original import |
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/EMEND |
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8月16日 | 阿瑞匹坦胶囊 | Aprepitant Capsules/意美 | 125mg | Capsule | Merck Sharp & Dohme Ltd. | original import |
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/EMEND |
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9月16日 | 双醋瑞因胶囊 | Diacerein Capsules/安必丁 | 50mg | Capsule | TRB Pharma S.A. | original import |
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10月16日 | 巯嘌呤片 | Mercaptopurine Tablets/Purinethol | 50mg | Tablet | Quinn Pharmaceuticals, LLC | FDA Licensed Generics | supplement |
11月16日 | 吗替麦考酚酯胶囊 | Mycophenolate Mofetil Capsules/Cellcept | 0.25g | Capsule | Roche Registration Ltd | EU-Listed(Origin: Germany;Listed country: UK) | supplement |
12月16日 | 阿苯达唑片 | Albendazole Tablets | 0.2g | Tablet | Smith Kline &French Laboratorles Ltd | Produced in China by original enterprises |
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16-13 | 那格列奈片 | Nateglinide Tablets/唐力 | 0.12g | Tablet | Beijing Novartis Pharma Ltd | Produced in China by original enterprises |
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16-14 | 拉米夫定片 | Lamivudine Tablets | 0.1g | Tablet | Glaxosmithkline Pharmaceuticals (Suzhou) Co. LTD | Produced in China by original enterprises |
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16-15 | 吗替麦考酚酯胶囊 | Mycophenolate Mofetil Capsuels | 0.25g | Capsule | Shanghai Roche Co. LTD | Produced in China by original enterprises |
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5月15日 | 格列齐特片 | Gliclazide Tablets/Diaprel | 80mg | Tablet | Les Laboratoires Servier | Estonia-Listed( Origin: France Or Ireland) | Generic Names Corrected to Gliclazide Tablets (Ⅱ) |
7月15日 | 盐酸坦索罗辛 | Tamsulosin Hydrochloride Sustained-release Capsules | 1g | Capsule (sustained release capsules) | Astellas Pharmaceutical (China) Co. LTD | Produced in China by original enterprises | Specification Corrected from “1g”to “0.2mg” |
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