List of Generic Reference Rreparations (19th Batch) |
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No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Notes |
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19-1 | 布洛芬混悬液 | Ibuprofen Suspension/CHILDREN’S MOTRIN | 5ml:100mg | suspension | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Orange Book-USA |
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19-2 | 桂利嗪片 | Cinnarizine Tablets/Stugeron | 25mg | tablet | JANSSEN CILAG S.P.A | EU-Listed(Listed country: Italy,Origin: Italy) |
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19-3 | 桂利嗪 | Cinnarizine Tablets/Stugeron | 75mg | capsule | JANSSEN CILAG S.P.A | EU-Listed(Listed country: Italy,Origin: Italy) |
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19-4 | 地喹氯铵含片 | Dequalinium Chloride Buccal Tablets/ SP TROCHES 0.25mg(MEIJI) | 0.25mg | tablet | MeijiSeikaファルマ株式会社 | Japan Listed |
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19-5 | 盐酸阿夫唑嗪 | Alfuzosin Hydrochloride Prolonged Release Tablets/(Xatral XL) | 10mg | tablet | Sanofi-aventis France | Original Import |
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19-6 | 沙格列汀二甲双胍(II) | Saxagliptin and Metformin Hydrochloride Sustained-release Tables/安立格(KOMBIGLYZE XR) | 5 mg of salagliptin and 500 mg of metformin hydrochloride per tablet | tablet(sustained release tablet) | AstraZeneca AB | Original Import |
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19-7 | 沙格列汀二甲双胍(II) | Saxagliptin and Metformin Hydrochloride Sustained-release Tables/安立格(KOMBIGLYZE XR) | 2.5 mg of salagliptin and 1000 mg of metformin hydrochloride per tablet | tablet(sustained release tablet) | AstraZeneca AB | Original Import |
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19-8 | 沙格列汀二甲双胍(II) | Saxagliptin and Metformin Hydrochloride Sustained-release Tables/(KOMBIGLYZE XR) | 2.5 mg of salagliptin and 1000 mg of metformin hydrochloride per tablet | tablet(sustained release tablet) | AstraZeneca AB | Original Import |
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19-9 | 达格列净片 | Dapagliflozin Tablets/(FORXIGA) | 5mg | tablet | AstraZeneca AB | Original Import |
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19-10 | 达格列净片 | Dapagliflozin Tablets/(FORXIGA) | 10mg | tablet | AstraZeneca AB | Original Import |
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19-11 | 阿戈美拉汀片 | Agomelatine Tablets/Valdoxan | 25mg | tablet | Les Laboratoires Servier | Original Import |
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19-12 | 铝碳酸镁混悬液 | Hydrotalcite Suspension/Talcid | 10ml:1g or 1g/packet | suspension | Bayer Vital GmbH | Listed country: Germany Origin: Spain |
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19-13 | 华法林钠片 | Warfarin Sodium Tablets/Marevan | 3mg | tablet | Orion Corporation Orion Pharma | Internationally recognized import |
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19-14 | 阿法骨化醇软 | Alfacalcidol Soft Capsules/Alpha D3 | 0.25μg | capsule(soft capsule) | Teva Pharmaceutical Industries Ltd. | Original Import |
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19-15 | 格列齐特片(Ⅱ) | Gliclazide Tablets(Ⅱ) | 80mg | tablet | Tianjin Hua Jin Pharmaceutical Co. LTD | Original technology transfer |
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19-16 | 依非韦伦片 | Efavirenz Tablets | 50mg | tablet | Zhejiang Huahai Pharmaceutical Co. LTD | Original technology transfer |
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19-17 | 依非韦伦片 | Efavirenz Tablets | 200mg | tablet | Zhejiang Huahai Pharmaceutical Co. LTD | Original technology transfer |
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19-18 | 依非韦伦片 | Efavirenz Tablets | 600mg | tablet | Zhejiang Huahai Pharmaceutical Co. LTD | Original technology transfer |
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List of Generic Reference Rreparations (120th Batch) |
No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Notes 1 | Notes2 |
20-1 | 氨甲环酸片 | Tranexamic Acid Tablets/Transamin | 250mg | tablet | DAIICHI SANKYO CO.,LTD. | Orange Book-Japan |
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20-2 | 氨甲环酸片 | Tranexamic Acid Tablets/Transamin | 500mg | tablet | DAIICHI SANKYO CO.,LTD. | Original Import |
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20-3 | 硫糖铝 | Sucralfate Suspensoid Gel/Sucrate | 5ml:1g | Suspension gel | Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. | EU-Listed(Listed country: Italy;Origin: Italy) |
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20-4 | 甲硝唑片 | Metronidazole Tablets/FLAGYL | 0.2g | tablet | Winthrop Pharmaceuticals UK Limited/Zentiva/Aventis Pharma Limited/Sanofi | EU-Listed(Listed country: UK; Origin: Spain) | Addition |
20-5 | 阿奇霉素干 | Azithromycin for Suspension | 100mg/袋 | Dry suspension | Pfizer Pharmaceuticals Ltd | Produced in China by original enterprises |
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20-6 | 盐酸舍曲林片 | Sertraline Hydrochloride Tablets | 50mg | tablet | Pfizer Pharmaceuticals Ltd | Produced in China by original enterprises |
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20-7 | 氟康唑 | Fluconazole Capsules | 50mg | capsule | Pfizer Pharmaceuticals Ltd | Produced in China by original enterprises |
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20-8 | 甲磺酸倍他司汀片 | Betahistine Mesilate Tablets | 6mg | tablet | Eisai (China) Pharmaceutical Co. LTD | Produced in China by original enterprises |
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20-9 | 富马酸喹硫平片 | Quetiapine Fumarate Tablets | 25mg | tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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20-10 | 富马酸喹硫平片 | Quetiapine Fumarate Tablets/Seroquel | 0.2g | tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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20-11 | 富马酸喹硫平片 | Quetiapine Fumarate Tablets | 0.3g | tablet | AstraZeneca Pharmaceutical Co Ltd | Produced in China by original enterprises |
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20-12 | 盐酸米诺环素 | Minocycline Hydrochloride Capsules | 50mg | capsule | Hanhui Pharmaceutical Co. LTD | Original technology transfer |
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20-13 | 盐酸米诺环素 | Minocycline Hydrochloride Capsules | 100mg | capsule | Hanhui Pharmaceutical Co. LTD | Original technology transfer |
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20-14 | 米非司酮片 | Mifepristone Tablets | 25mg | tablet | China Resources Zizhu Pharmaceutical Co. LTD | Domestic specific specifications |
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20-15 | 米非司酮片 | Mifepristone Tablets | 10mg | tablet | China Resources Zizhu Pharmaceutical Co. LTD | Domestic specific specifications |
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