| List of Reference Preparations for Generic Drugs (batch 17) |
| No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note 1 | Note 2 |
| 17-1 | 来氟米特片 | Leflunomide Tablets/ARAVA | 10mg | tablet | Sanofi-Aventis Us LLC | Orange Book-USA |
|
| 17-2 | 来氟米特片 | Leflunomide Tablets/ARAVA | 20mg | tablet | Sanofi-Aventis Us LLC | Orange Book-USA |
|
| 17-3 | 硫普罗宁片 | Tiopronin Tablets/ Thiola | 100mg | tablet | Mylan Pharmaceutical Co.,Ltd | Orange Book-Japan |
|
| 17-4 | 阿莫西林克拉维酸钾干糖浆（14:1） | CLAVAMOX Dry Syrup | 636.5mg（1g） | Dry syrup (dry suspension) | Glaxo Smithkline K.K. | Orange Book-Japan | There is no dry suspension in Japan. The original dosage form in Japan is dry syrup |
| 17-5 | 右美沙芬缓释混悬液 | Dextromethorphan Sustained Release Suspension / Delsym | 30mg/5ml | suspension | Reckitt Benckiser LLC | Orange Book-USA |
|
| 17-6 | 盐酸贝尼地平片 | Benidipine Hydrochloride Tablets/ CONIEL | 2mg | tablet |
Kyowa Hakko Kirin Co.,Ltd | Orange Book-Japan |
|
| 17-7 | 盐酸贝尼地平片 | Benidipine Hydrochloride Tablets | 4mg | tablet |
Kyowa Hakko Kirin Co.,Ltd | Original Import |
|
| 17-8 | 盐酸贝尼地平片 | Benidipine Hydrochloride Tablets | 8mg | tablet |
Kyowa Hakko Kirin Co.,Ltd | Original Import |
|
| 17-9 | 制霉菌素片 | Nystatin Tablets / NYSTATIN | 500000 units | tablet | TEVA PHARMACEUTICALS USA INC | Orange Book-USA |
|
| 17-10 | 奥硝唑片 | Ornidazole Tablets/Tiberal | 0.5g | tablet | OrPha Swiss GmbH | Original Technology Transfer，Listed Country: Swiss，Origin: Swit |
|
| 17-11 | 奥硝唑片 | Ornidazole Tablets/Tiberal | 0.5g | tablet | SERB | Original Technology Transfer，Listed Country: France，Origin: France |
|
| 17-12 | 琥珀酸美托洛尔缓释片 | Metoprolol Succinate Sustained-release Tablets/Betaloc ZOK | 23.75mg | tablet
(Sustained release tablet) | AstraZeneca AB | Original Import |
|
|
| 17-13 | 琥珀酸美托洛尔缓释片 | Metoprolol Succinate Sustained-release Tablets/Betaloc ZOK | 95mg | tablet
(Sustained release tablet) | AstraZeneca AB | Original Import |
|
|
| 17-14 | 琥珀酸美托洛尔缓释片 | Metoprolol Succinate Sustained-release Tablets/Betaloc ZOK | 190mg | tablet | AstraZeneca AB | Original Import |
|
| (Sustained release tablet) |
| 17-15 | 盐酸西那卡塞片 | Cinacalcet Hydrochloride Tablets | 25mg | tablet |
Kyowa Hakko Kirin Co.,Ltd | Original Import |
|
| 17-16 | 盐酸西那卡塞片 | Cinacalcet Hydrochloride Tablets | 75mg | (Sustained release tablet) |
Kyowa Hakko Kirin Co.,Ltd | Original Import |
|
| 17-17 | 兰索拉唑口崩片 | Lansoprazole Orally Disintegrating Tablets | 15mg | tablet
(Orally disintegrating tablet) | Takeda Pharmaceutical Company Limited | Original Import |
|
|
| 17-18 | 兰索拉唑口崩片 | Lansoprazole Orally Disintegrating Tablets | 30mg | tablet
(Orally disintegrating tablet) | Takeda Pharmaceutical Company Limited | Original Import |
|
|
| 17-19 | 利培酮口崩片 | Risperidone Orally Disintegrating Tablets/Risperdal | 0.5mg | tablet
(Orally disintegrating tablet) | Janssen Pharmaceutical K.K | Orange Book-Japan | Supplement |
|
| 17-20 | 利培酮口崩片 | Risperidone Orally Disintegrating Tablets/Risperdal | 1mg | tablet
(Orally disintegrating tablet) | Janssen Pharmaceutical K.K | Orange Book-Japan | Supplement |
|
| 17-21 | 利培酮口崩片 | Risperidone Orally Disintegrating Tablets/Risperdal | 2mg | tablet
(Orally disintegrating tablet) | Janssen Pharmaceutical K.K | Orange Book-Japan | Supplement |
|
| 17-22 | 阿维A胶囊 | Acitretin Capsules/Neotigason | 10mg | Capsule | Actavis Group PTC ehf. | EU-Listed（Origin: France；Listed country: UK） | Supplement |
| 17-23 | 卡马西平片 | Carbamazepine Tablets | 0.2g | tablet | Novartis Pharma Schweiz AG | Produced in China by original enterprises |
|
| 17-24 | 双氯芬酸钠肠溶片 | Diclofenac Sodium Enteric-coated Tablets | 25mg | Novartis Pharma Schweiz AG | Produced in China by original enterprises |
|
| 17-25 | 布洛芬缓释胶囊 | Ibuprofen Sustained Release Capsules | 0.3g | Capsule
（sustained release capsule） | Sino - American Skis Pharmaceutical Co. LTD( Tianjin) | Produced in China by original enterprises |
|
|
| 17-26 | 铝碳酸镁片 | Hydrotalcite Tablets | 0.5g | tablet | Bayer HealthCare AG | Produced in China by original enterprises |
|
| 17-27 | 精氨酸布洛芬颗粒 | Ibuprofen Arginine Granules | 0.2g | Granules | Hainan Zambon Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
| 17-28 | 精氨酸布洛芬颗粒 | Ibuprofen Arginine Granules | 0.4g | Granules | Hainan Zambon Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
| 17-29 | 精氨酸布洛芬颗粒 | Ibuprofen Arginine Granules | 0.6g | Granules | Hainan Zambon Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
| 17-30 | 甲苯咪唑片 | Mebendazole Tablets | 0.1g | tablet | Xian-Janssen Pharmaceutical Ltd | Produced in China by original enterprises |
|
| 17-31 | 盐酸特比萘芬片 | Terbinafine Hydrochloride Tablets | 0.25g | tablet | Novartis Pharma Schweiz AG | Produced in China by original enterprises |
|
| 17-32 | 阿德福韦酯片 | Adefovir Dipivoxil Tablets | 10mg | tablet | Glaxosmithkline (Tianjin) LTD | Produced in China by original enterprises |
|
| List of Reference Preparations for Generic Drugs (batch 18) |
| No. | Generic Name | English Name/Proprietary Name | Strength | Dosage Form | Applicant Holder | Note 1 | Note 2 |
| 18-1 | 盐酸乙哌立松片 | Eperisone Hydrochloride | 50mg | tablet | Eisai Co.,Ltd. | Orange Book-Japan |
|
| /Myonal |
| 18-2 | 熊去氧胆酸片 | Ursodeoxycholic Acid Tablets | 0.25g | tablet | ALLERGAN SALES LLC/Aptalis Pharma US Inc. | Orange Book-USA | Supplement |
| /URSO 250 |
| 18-3 | 头孢特仑新戊酯片 | Cefteram Pivoxil Tablets | 0.1g | tablet | Toyama Chemical Co., Ltd. | Original Import |
|
| /TOMIRON |
| 18-4 | 头孢特仑新戊酯片 | Cefteram Pivoxil Tablets | 50mg | tablet | Toyama Chemical Co., Ltd. | Original Import |
|
| /TOMIRON |
| 18-5 | 奥替溴铵片 | Otilonium Bromide Tablets | 40mg | tablet | A.Menarini Industrie Farmaceutiche Riunite S.r.l | Original Import |
|
| /Spasmomen |
| 18-6 | 磷酸雌莫司汀胶囊 | Estramustine Phosphate Capsules | 0.14g | Capsule | Pfizer Italia S.r.l. | Original Import |
|
| /Estracyt |
| 18-7 | 重酒石酸卡巴拉汀胶囊 | Rivastigmine Hydrogen Tartrate | 1.5mg | Capsule | Novartis Europharm Limited | Original Import |
|
| Capsules/Exelon |
| 18-8 | 重酒石酸卡巴拉汀胶囊 | Rivastigmine Hydrogen Tartrate | 3.0mg | Capsule | Novartis Europharm Limited | Original Import |
|
| Capsules/Exelon |
| 18-9 | 重酒石酸卡巴拉汀胶囊 | Rivastigmine Hydrogen Tartrate | 6.0mg | Capsule | Novartis Europharm Limited | Original Import |
|
| Capsules/Exelon |
| 18-10 | 琥珀酸索利那新片 | Solifenacin Succinate Tablets | 5mg | tablet | Astellas Pharma Europe B.V | Original Import |
|
| /Vesicare |
| 18-11 | 盐酸乙哌立松片 | Eperisone Hydrochloride Tablets | 50mg | film-coated tablets | Eisai (China) Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
| 18-12 | 雷贝拉唑钠 | Rabeprazole Sodium Enteric-coated Tablets | 10mg | tablet
（ enteric coatel tablets） | Eisai (China) Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
|
| 18-13 | 雷贝拉唑钠 | Rabeprazole Sodium Enteric-coated Tablets | 20mg | tablet
（ enteric coatel tablets） | Eisai (China) Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
|
| 18-14 | 乙酰半胱氨酸颗粒 | Acetylcysteine Granules | 0.1g | Granules | Hainan Zambon Pharmaceutical Co. LTD | Produced in China by original enterprises |
|
| 18-15 | 乙酰半胱氨酸颗粒 | Acetylcysteine Granules | 0.2g | Granules | Hainan Zambon Pharmaceutical Co. LTD | Produced in China by original enterprises |
|