| List of Generic Reference Preparations (5th & 6th batches) |
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| List of Generic Reference Preparations (5th batch) |
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| No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note1 | Note2 |
| 5-1 | 艾司唑仑片 | Estazolam Tablets/EURODIN | 1mg | tablet | Teva Takeda Yakuhin Ltd. | Orange Book-Japan |
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| 5-2 | 艾司唑仑片 | Estazolam Tablets/EURODIN | 2mg | tablet | Teva Takeda Yakuhin Ltd. | Orange Book-Japan |
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| 5-3 | 氨茶碱片 | Aminophylline Tablets/Neophyllin | 0.1g（On the Basis of C2H8N2（C7H8N4O2）2·2H2O） | tablet | Sannova Co., Ltd. | Orange Book-Japan | Japan Listed Name：Aminophylline Hydrate Tablets |
| 5-4 | 丙硫氧嘧啶片 | Propylthiouracil Tablets/Propylthiouracil | 50mg | tablet | Dava Pharmaceuticals INC | Orange Book-USA |
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| 5-5 | 醋酸甲地孕酮片 | Megestrol Acetate Tablets/Megace | 0.16g | tablet | PharmaSwiss Česká republika s.r.o. | EU-Listed（Origin：England） |
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| 5-6 | 地高辛片 | Digoxin Tablets/Lanoxin | 0.25mg | tablet | Concordia Pharmaceuticals Inc | Orange Book-USA |
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| 5-7 | 多潘立酮片 | Domperidone Tablets/Motilium | 10mg | tablet | Janssen-Cilag (Val de Reuil) France | EU-Listed（Listed Country：France；Origin：France） | France Listed Name：Domperidone Film-coated Tablets |
| 5-8 | 奋乃静片 | Perphenazine Tablets/PERPHENAZINE | 2mg | tablet | SANDOZ INC | Orange Book-USA |
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| 5-9 | 奋乃静片 | Perphenazine Tablets/PERPHENAZINE | 4mg | tablet | SANDOZ INC | Orange Book-USA |
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| 5-10 | 复方地芬诺酯片 | Compound Diphenoxylate Hydrochloride Tablets/Lomotil | Diphenoxylate Hydrochloride 2.5mg，Diphenoxylate Hydrochloride 25μg | tablet | GD SEARLE LLC | Orange Book-USA | America Listed Name：diphenoxylate hydrochloride
and atropine sulfate tablets |
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| 5-11 | 格列本脲片 | Glibenclamide Tablets/Daonil | 2.5mg | tablet | sanofi K.K. | Orange Book-Japan |
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| 5-12 | 枸橼酸他莫昔芬片 | Tamoxifen Citrate Tablets/Nolvadex | 10mg（On the Basis of tamoxifen） | tablet | Astrazeneca K.K. | Orange Book-Japan |
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| 5-13 | 红霉素肠溶胶囊 | Erythromycin Enteric Capsules/ERYC | 0.25g（250000 units） | Capsule | Mayne Pharma International Pty Ltd | Orange Book-USA | America Listed Name：Erythromycin delayed-release capsules |
| 5-14 | 红霉素Enteric-coated Tablets | Erythromycin Enteric-coated Tablets/ERY-TAB | 0.25g（250000 units） | tablet | Arbor Pharmaceuticals LLC | Orange Book-USA | America Listed Name：Erythromycin delayed-release tablets |
| 5-15 | 琥珀酸亚铁片 | Ferrous Succinate Tablets/INOFER | 0.1g | tablet | LABORATOIRE DE L’ INOFER | EU-Listed（Listed Country：France；Origin：France） |
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| 5-16 | 华法林钠片 | Warfarin Sodium Tablets/Coumadin | 2.5mg | tablet | Bristol Myers Squibb Pharma Co | Orange Book-USA |
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| 5-17 | 华法林钠片 | Warfarin Sodium Tablets/Coumadin | 5mg | tablet | Bristol Myers Squibb Pharma Co | Orange Book-USA |
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| 5-18 | 己烯雌酚片 | Diethylstilbestrol Tablets /DISTILBENE | 1mg | tablet | LABORATOIRES GERDA | EU-Listed（Listed Country：France；Origin：France） |
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| 5-19 | 卡托普利片 | Captopril Tablets/CAPTORIL | 12.5mg | tablet | Daiichi Sankyo Espha Co., Ltd. | Orange Book-Japan |
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| 5-20 | 卡托普利片 | Captopril Tablets/CAPTORIL | 25mg | tablet | Daiichi Sankyo Espha Co., Ltd. | Orange Book-Japan |
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| 5-21 | 利培酮片 | Risperidone Tablets/Risperdal | 1mg | tablet | Janssen Pharmaceuticals Inc | Orange Book-USA |
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| 5-22 | 利培酮片 | Risperidone Tablets/Risperdal | 2mg | tablet | Janssen Pharmaceuticals Inc | Orange Book-USA |
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| 5-23 | 柳氮磺吡啶Enteric-coated Tablets | Sulfasalazine Enteric-coated Tablets/Azulfidine | 0.25g | tablet（Enteric-coated Tablets） | Pfizer Japan Inc. | Orange Book-Japan | Japan Listed NameSalazosulfapyridine Enteric-coated Tablets |
| 5-24 | 马来酸多潘立酮片 | Domperidone Maleate Tablets/Motilium | 10mg（On the Basis of C22H24ClN5O2） | tablet | Johnson & Johnson Consumer N.V./S.A.-Belgium | EU-Listed （ Listed Country：Belgium；Origin：France) | Belgium Listed Name：Domperidone Maleate Film-coated Tablets |
| 5-25 | 麦角胺咖啡因片 | Ergotamine and Caffeine Tablets/CAFERGOT | Ergotamine Tartrate 1mg，Anhydrous Caffeine 100mg | tablet | SANDOZ INC | Orange Book-USA | America Listed Name：Ergotamine Tartrate and Caffeine Tablets |
| 5-26 | 蒙脱石散 | Montmorillonite Powder/SMECTA | 3g | Powders | IPSEN PHARMA | EU-Listed（Listed Country：France；Origin：France） |
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| 5-27 | 米非司酮片 | Mifepristone Tablets/Mifegyne | 0.2g | tablet | EXELGYN | EU-Listed（Listed Country：France；Origin：France） |
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| 5-28 | 诺氟沙星片 | Norfloxacin Tablets/BACCIDAL | 0.1g | tablet | KYORIN Pharmaceutical Co.,Ltd. | Orange Book-Japan |
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| 5-29 | 氢化可的松片 | Hydrocortisone Tablets/Cortef | 10mg | tablet | PHARMACIA AND UPJOHN CO | Orange Book-USA |
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| 5-30 | 氢化可的松片 | Hydrocortisone Tablets/Cortef | 20mg | tablet | PHARMACIA AND UPJOHN CO | Orange Book-USA |
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| 5-31 | 舒必利片 | Sulpiride Tablets/Abilit | 0.1g | tablet | Dainippon Sumitomo Pharma Co., Ltd. | Orange Book-Japan |
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| 5-32 | 舒必利片 | Sulpiride Tablets/Abilit | 50mg | tablet | Dainippon Sumitomo Pharma Co., Ltd. | Orange Book-Japan |
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| 5-33 | 替加氟胶囊 | Tegafur Capsules/Futraful | 0.2g | Capsule | TAIHO PHARMACEUTICAL CO., LTD. | Orange Book-Japan |
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| 5-34 | 替硝唑片 | Tinidazole Tablets/Fasigyn | 0.5g | tablet | Pfizer Limited | EU-Listed(Listed Country：England；Origin：France) |
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| 5-35 | 硝酸异山梨酯片 | Isosorbide Dinitrate Tablets/ISORDIL | 5mg | tablet | VALEANT PHARMACEUTICALS NORTH AMERICA LLC | Orange Book-USA |
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| 5-36 | 盐酸地尔硫䓬片 | Diltiazem Hydrochloride Tablets/ HERBESSER | 30mg | tablet | Mitsubishi Tanabe Pharma Corporation | Orange Book-Japan |
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| 5-37 | 盐酸二甲双胍片 | Metformin Hydrochloride Tablets/Glycoran | 0.25g | tablet | NIPPON SHINYAKU CO.,LTD. | Orange Book-Japan |
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| 5-38 | 盐酸二甲双胍片 | Metformin Hydrochloride Tablets/Glucophage | 0.5g | tablet | Merck Santé S.A.S | EU-Listed（Listed Country：France；Origin：France） |
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| 5-39 | 盐酸雷尼替丁胶囊 | Ranitidine Hydrochloride Capsules／RANITIDINE HYDROCHLORIDE | 0.15g（On the Basis of C13H22N403S） | Capsule | SANDOZ INC | Orange Book-USA |
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| 5-40 | 盐酸雷尼替丁片 | Ranitidine Hydrochloride Tablets／Zantac | 0.15g（On the Basis of C13H22N403S） | tablet | Glaxo SmithKline UK | EU-Listed：（Listed Country：England；Origin：Germany） |
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| 5-41 | 盐酸美西律片 | Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride | 50mg | tablet | KYOWA CritiCare Co., Ltd | Orange Book-Japan |
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| 5-42 | 盐酸美西律片 | Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride | 0.1g | tablet | KYOWA CritiCare Co., Ltd | Orange Book-Japan |
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| 5-43 | 盐酸帕罗西汀片 | Paroxetine Hydrochloride/Paxil | 20mg（On the Basis of C19H20FNO3） | tablet | Apotex Technologies Inc | Orange Book-USA |
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| 5-44 | 盐酸乙胺丁醇片 | Ethambutol Hydrochloride Tables/Ebutol | 0.25g | tablet | Kaken Pharmaceutical Co.,Ltd. | Orange Book-Japan |
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| 5-45 | 异烟肼片 | Isoniazid Tablets/Isoniazid | 0.3g | tablet | SANDOZ INC | Orange Book-USA |
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| 5-46 | 异烟肼片 | Isoniazid Tablets/Isoniazid | 0.1g | tablet | SANDOZ INC | Orange Book-USA |
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| 5-47 | 盐酸普萘洛尔片 | Propranolol Hydrochloride Tablets/Inderal | 10mg | tablet | AstraZeneca K.K. | Orange Book-Japan |
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| 5-48 | 丙硫氧嘧啶片 | Propylthiouracil Tablets/PROPYL-THYRACIL | 0.1g | tablet | Paladin Labs Inc | Listed Country：Canada |
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| 5-49 | 磷酸氯喹片 | Chloroquine Phosphate Tablets/Resochin | 0.25g（On the Basis of Chloroquine C18H26ClN3155mg） | tablet | Bayer Vital GmbH | EU-Listed（Listed Country：Germany；Origin：Germany |
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| List of Generic Reference Preparations (6th batch) |
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| No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note1 | Note2 |
| 6月1日 | 草酸艾司西酞普兰片 | Escitalopram Oxalate Tablets/Lexapro | 5mg(On the Basis of C20H21FN2O) | tablet | H. Lundbeck A/S | Original Import |
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| 6月2日 | 草酸艾司西酞普兰片 | Escitalopram Oxalate Tablets/Lexapro | 10mg(On the Basis of C20H21FN2O) | tablet | H. Lundbeck A/S | Original Import |
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| 6月3日 | 草酸艾司西酞普兰片 | Escitalopram Oxalate Tablets/Lexapro | 20mg(On the Basis of C20H21FN2O) | tablet | H. Lundbeck A/S | Original Import |
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| 6月4日 | 多潘立酮口崩片 | Domperidone Orally Disintegrating Tablets/Motilium | 10mg | tablet | Janssen-Cilag AG - Switzerland | EU-Listed （ Listed Country：Switzerland；Origin：England) | Switzerland Listed Name：Domperidone Orodispersible Tablets |
| 6月5日 | 恩替卡韦片 | Entecavir Tablets /BARACLUDE | 0.5mg | tablet | BRISTOL MYERS SQUIBB | Orange Book-USA |
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| 6月6日 | 恩替卡韦片 | Entecavir Tablets /BARACLUDE | 1mg | tablet | BRISTOL MYERS SQUIBB | Orange Book-USA |
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| 6月7日 | 红霉素 | Erythromycin Enteric-coated Tablets/ERY-TAB | 0.5g（500000 units） | tablet | Arbor Pharmaceuticals LLC | Orange Book-USA | America Listed Name：Erythromycin delayed-release tablets |
| 6月8日 | 甲磺酸倍他司汀片 | Betahistine Mesilate Tablets/Merislon | 6mg | tablet | Eisai Co., Ltd. | Orange Book-Japan |
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| 6月9日 | 利培酮片 | Risperidone Tablets/Risperdal | 3mg | tablet | Janssen Pharmaceuticals Inc | Orange Book-USA |
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| 6月10日 | 磷酸奥司他韦胶囊 | Oseltamivir Phosphate Capsules/ Tamiflu | 75mg（On the Basis of C16H28N2O4） | Capsule | Roche Registration Ltd. | Original Import |
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| 6月11日 | 硫酸氨基葡萄糖胶囊 | Glucosamine Sulfate Capsules/Viartril-S | 0.25g(On the Basis of Glucosamine sulfate) | Capsule | ROTTAPHARM S.P.A | Original Import | Applicable to: glucosamine sulfate mixture containing sodium chloride |
| 6月12日 | 硫酸羟氯喹片 | Hydroxychloroquine Sulfate Tablets/Plaquenil | 0.2g | tablet | Aventis Pharma Limited | Original Import |
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| 6月13日 | 匹伐他汀钙片 | Pitavastatin CalciumTablets /Livalo Kowa | 1mg | tablet | Kowa Company, Ltd. | Original Import |
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| 6月14日 | 匹伐他汀钙片 | Pitavastatin CalciumTablets /Livalo Kowa | 2mg | tablet | Kowa Company, Ltd. | Original Import |
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| 6月15日 | 氢溴酸西酞普兰片 | Citalopram Hydrobromide Tablets/Cipramil | 20mg(On the Basis of C20H21FN2O) | tablet | H. Lundbeck A/S | Original Import |
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| 6月16日 | 头孢地尼胶囊 | Cefdinir Capsules/Cefzon | 0.1g | Capsule | Astellas Pharma Inc. | Original Import |
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| 6月17日 | 缬沙坦胶囊 | Valsartan Capsules/DIOVAN | 40mg | Capsule | Novartis Pharmaceuticals UK Limited | EU-Listed（Listed Country：England；Origin：Switzerland） |
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| 6月18日 | 缬沙坦胶囊 | Valsartan Capsules/DIOVAN | 0.16g | Capsule | Novartis Pharmaceuticals UK Limited | EU-Listed（Listed Country：England；Origin：Switzerland） |
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| 6月19日 | 缬沙坦片 | Valsartan Tablets/DIOVAN | 0.16g | tablet | NOVARTIS PHARMACEUTICALS CORP | Orange Book-USA |
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| 6月20日 | 缬沙坦片 | Valsartan Tablets/DIOVAN | 80mg | tablet | NOVARTIS PHARMACEUTICALS CORP | Orange Book-USA |
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| 6月21日 | 缬沙坦片 | Valsartan Tablets/DIOVAN | 40mg | tablet | NOVARTIS PHARMACEUTICALS CORP | Orange Book-USA |
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| 6月22日 | 盐酸
乙胺丁醇片 | Ethambutol Hydrochloride Tablets/Myambutol | 0.4g | tablet | STI Pharma LLC | Orange Book-USA |
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| 6月23日 | 盐酸地尔硫䓬片 | Diltiazem Hydrochloride Tablets/ HERBESSER | 60mg | tablet | Mitsubishi Tanabe Pharma Corporation | Orange Book-Japan |
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| 6月24日 | 盐酸二甲双胍缓释片 | Metformin Hydrochloride Sustained-release Tablets/GLUCOPHAGE XR | 0.5g | Sustained Release Tablets | BRISTOL MYERS SQUIBB CO | Orange Book-USA |
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| 6月25日 | 盐酸二甲双胍片 | Metformin Hydrochloride Tablets/Glucophage | 0.85g | tablet | Merck Santé S.A.S | EU-Listed（Listed Country：France；Origin：France） |
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| 6月26日 | 盐酸雷尼替丁片 | Ranitidine Hydrochloride Tablets／Zantac | 75mg（On the Basis of C13H22N403S） | tablet | Glaxo SmithKline K.K | Orange Book-Japan |
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| 6月27日 | 盐酸美西律胶囊 | Mexiletine Hydrochloride Capsules/Mexitil | 50mg | Capsule | Nippon Boehringer Ingelheim Co., Ltd. | Orange Book-Japan |
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| 6月28日 | 盐酸美西律胶囊 | Mexiletine Hydrochloride Capsules/Mexitil | 0.1g | Capsule | Nippon Boehringer Ingelheim Co., Ltd. | Orange Book-Japan |
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| 6月29日 | 盐酸特比萘芬片 | Terbinafine Hydrochloride Tablets/Lamisil | 0.125g（On the Basis of C21H25N） | tablet | Sun Pharmaceutical Industries Limited | Orange Book-Japan |
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| 6月30日 | 盐酸特比萘芬片 | Terbinafine Hydrochloride Tablets/Lamisil | 0.25g（On the Basis of C21H25N） | tablet | NOVARTIS PHARMACEUTICALS CORP | Orange Book-USA |
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| 6-31 | 盐酸西替利嗪口崩片 | Cetirizine Hydrochloride Orally | 10mg | tablet（Orally Disintegrating Tablet） | Johnson and Johnson Consumer Inc Mcneil Consumer Healthcare Division | Orange Book-USA |
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| Disintegrating Tablets/Zyrtec Allergy |
| 6-32 | 盐酸西替利嗪片 | Cetirizine Hydrochloride Tablets/Zyrtec | 10mg | tablet | UCB-Pharma AG | Original Import |
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| 6-33 | 盐酸左西替利嗪片 | Levocetirizine Hydrochloride Tablets/Xyzal | 5mg | tablet | UCB Pharma AG | Original Import |
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| 6-34 | 硬脂酸红霉素片 | Erythromycin Stearate Tablets/ERYTHROCIN STEARATE | 0.25g（On the Basis of C37H67NO13，250000 units） | tablet | Arbor Pharmaceuticals LLC | Orange Book-USA |
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| 6-35 | 阿司匹林肠溶胶囊 | Aspirin Enteric Capsules/Astrix | 0.1g | Capsule（Enteric Capsule） | Mayne Pharma International Pty Ltd | Listed Country：Australia |
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