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Contact Us The seventeenth batch

List of Reference Preparations for Generic Drugs (batch 17)
No.Generic NameEnglish Name/Proprietary NameStrengthDosage FormApplicant HolderNote 1Note 2
17-1来氟米特片Leflunomide Tablets/ARAVA10mgtabletSanofi-Aventis Us LLCOrange Book-USA
17-2来氟米特片Leflunomide Tablets/ARAVA20mgtabletSanofi-Aventis Us LLCOrange Book-USA
17-3硫普罗宁片Tiopronin Tablets/ Thiola100mgtabletMylan Pharmaceutical Co.,LtdOrange Book-Japan
17-4阿莫西林克拉维酸钾干糖浆(14:1)CLAVAMOX Dry Syrup636.5mg(1g)Dry syrup (dry suspension)Glaxo Smithkline K.K.Orange Book-JapanThere 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 / Delsym30mg/5mlsuspensionReckitt Benckiser LLCOrange Book-USA
17-6盐酸贝尼地平片Benidipine Hydrochloride Tablets/ CONIEL2mgtablet
Kyowa Hakko Kirin Co.,Ltd 
Orange Book-Japan
17-7盐酸贝尼地平片Benidipine Hydrochloride Tablets4mgtablet
Kyowa Hakko Kirin Co.,Ltd 
Original Import
17-8盐酸贝尼地平片Benidipine Hydrochloride Tablets8mgtablet
Kyowa Hakko Kirin Co.,Ltd 
Original Import
17-9制霉菌素片Nystatin Tablets / NYSTATIN500000 unitstabletTEVA PHARMACEUTICALS USA INCOrange Book-USA
17-10奥硝唑片Ornidazole Tablets/Tiberal0.5gtabletOrPha Swiss GmbHOriginal Technology Transfer,Listed Country: Swiss,Origin: Swit
17-11奥硝唑片Ornidazole Tablets/Tiberal0.5gtabletSERBOriginal 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 ZOK23.75mgtablet
(Sustained release tablet)
AstraZeneca ABOriginal Import

17-13琥珀酸美托洛尔缓释片Metoprolol Succinate Sustained-release Tablets/Betaloc ZOK95mgtablet
(Sustained release tablet)
AstraZeneca ABOriginal Import

17-14琥珀酸美托洛尔缓释片Metoprolol Succinate Sustained-release Tablets/Betaloc ZOK190mgtabletAstraZeneca ABOriginal Import

(Sustained release tablet)
17-15盐酸西那卡塞片Cinacalcet Hydrochloride Tablets25mgtablet
Kyowa Hakko Kirin Co.,Ltd 
Original Import
17-16盐酸西那卡塞片Cinacalcet Hydrochloride Tablets75mg(Sustained release tablet)
Kyowa Hakko Kirin Co.,Ltd 
Original Import
17-17兰索拉唑口崩片Lansoprazole Orally Disintegrating Tablets15mgtablet
(Orally disintegrating tablet)
Takeda Pharmaceutical Company LimitedOriginal Import

17-18兰索拉唑口崩片Lansoprazole Orally Disintegrating Tablets30mgtablet
(Orally disintegrating tablet)
Takeda Pharmaceutical Company LimitedOriginal Import

17-19利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal0.5mgtablet
(Orally disintegrating tablet)
Janssen Pharmaceutical K.KOrange Book-JapanSupplement

17-20利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal1mgtablet
(Orally disintegrating tablet)
Janssen Pharmaceutical K.KOrange Book-JapanSupplement

17-21利培酮口崩片Risperidone Orally Disintegrating Tablets/Risperdal2mgtablet
(Orally disintegrating tablet)
Janssen Pharmaceutical K.KOrange Book-JapanSupplement

17-22阿维A胶囊Acitretin Capsules/Neotigason10mgCapsuleActavis Group PTC ehf.EU-Listed(Origin: France;Listed country: UK)Supplement
17-23卡马西平片Carbamazepine Tablets0.2gtabletNovartis Pharma Schweiz AGProduced in China by original enterprises 
17-24双氯芬酸钠肠溶片Diclofenac Sodium Enteric-coated Tablets25mgNovartis Pharma Schweiz AGProduced in China by original enterprises 
17-25布洛芬缓释胶囊Ibuprofen Sustained Release Capsules0.3gCapsule
(sustained release capsule)
Sino - American Skis Pharmaceutical Co. LTD( Tianjin)Produced in China by original enterprises 
17-26铝碳酸镁片Hydrotalcite Tablets0.5gtabletBayer HealthCare AGProduced in China by original enterprises 
17-27精氨酸布洛芬颗粒Ibuprofen Arginine Granules0.2gGranulesHainan Zambon Pharmaceutical Co. LTDProduced in China by original enterprises 
17-28精氨酸布洛芬颗粒Ibuprofen Arginine Granules0.4gGranulesHainan Zambon Pharmaceutical Co. LTDProduced in China by original enterprises 
17-29精氨酸布洛芬颗粒Ibuprofen Arginine Granules0.6gGranulesHainan Zambon Pharmaceutical Co. LTDProduced in China by original enterprises 
17-30甲苯咪唑片Mebendazole Tablets0.1gtabletXian-Janssen Pharmaceutical LtdProduced in China by original enterprises 
17-31盐酸特比萘芬片Terbinafine Hydrochloride Tablets0.25gtabletNovartis Pharma Schweiz AGProduced in China by original enterprises 
17-32阿德福韦酯片Adefovir Dipivoxil Tablets10mgtabletGlaxosmithkline (Tianjin) LTDProduced in China by original enterprises 
List of Reference Preparations for Generic Drugs (batch 18)
No.Generic NameEnglish Name/Proprietary NameStrengthDosage FormApplicant HolderNote 1Note 2
18-1盐酸乙哌立松片Eperisone Hydrochloride50mgtabletEisai Co.,Ltd.Orange Book-Japan
/Myonal
18-2熊去氧胆酸片Ursodeoxycholic Acid Tablets0.25gtabletALLERGAN SALES LLC/Aptalis Pharma US Inc.Orange Book-USASupplement
/URSO 250
18-3头孢特仑新戊酯片Cefteram Pivoxil Tablets0.1gtabletToyama Chemical Co., Ltd.Original Import
/TOMIRON
18-4头孢特仑新戊酯片Cefteram Pivoxil Tablets50mgtabletToyama Chemical Co., Ltd.Original Import
/TOMIRON
18-5奥替溴铵片Otilonium Bromide Tablets40mgtabletA.Menarini Industrie Farmaceutiche Riunite S.r.lOriginal Import
/Spasmomen
18-6磷酸雌莫司汀胶囊Estramustine Phosphate Capsules0.14gCapsulePfizer Italia S.r.l.Original Import
/Estracyt
18-7重酒石酸卡巴拉汀胶囊Rivastigmine Hydrogen Tartrate1.5mgCapsuleNovartis Europharm LimitedOriginal Import
Capsules/Exelon
18-8重酒石酸卡巴拉汀胶囊Rivastigmine Hydrogen Tartrate3.0mgCapsuleNovartis Europharm LimitedOriginal Import
Capsules/Exelon
18-9重酒石酸卡巴拉汀胶囊Rivastigmine Hydrogen Tartrate6.0mgCapsuleNovartis Europharm LimitedOriginal Import
Capsules/Exelon
18-10琥珀酸索利那新片Solifenacin Succinate Tablets5mgtabletAstellas Pharma Europe B.VOriginal Import
/Vesicare
18-11盐酸乙哌立松片Eperisone Hydrochloride Tablets50mgfilm-coated tabletsEisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises 
18-12雷贝拉唑钠 Rabeprazole Sodium Enteric-coated Tablets10mgtablet
( enteric coatel tablets)
Eisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises 
18-13雷贝拉唑钠 Rabeprazole Sodium Enteric-coated Tablets20mgtablet
( enteric coatel tablets)
Eisai (China) Pharmaceutical Co. LTDProduced in China by original enterprises 
18-14乙酰半胱氨酸颗粒Acetylcysteine Granules0.1gGranulesHainan Zambon Pharmaceutical Co. LTDProduced in China by original enterprises 
18-15乙酰半胱氨酸颗粒Acetylcysteine Granules0.2gGranulesHainan Zambon Pharmaceutical Co. LTDProduced in China by original enterprises 

 



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