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Contact Us The fifth and sixth batch
List of Generic Reference Preparations (5th & 6th batches) 








List of Generic Reference Preparations (5th batch) 








No.Generic NameEnglish Name/Proprietary NameStrengthDosage FormApplicant HolderNote1Note2
5-1艾司唑仑片Estazolam Tablets/EURODIN1mgtabletTeva Takeda Yakuhin Ltd.Orange Book-Japan
5-2艾司唑仑片Estazolam Tablets/EURODIN2mgtabletTeva Takeda Yakuhin Ltd.Orange Book-Japan
5-3氨茶碱片Aminophylline Tablets/Neophyllin0.1g(On the Basis of  C2H8N2(C7H8N4O2)2·2H2O)tabletSannova Co., Ltd.Orange Book-JapanJapan Listed Name:Aminophylline Hydrate Tablets
5-4丙硫氧嘧啶片Propylthiouracil Tablets/Propylthiouracil50mgtablet Dava Pharmaceuticals INCOrange Book-USA
5-5醋酸甲地孕酮片Megestrol Acetate Tablets/Megace0.16gtabletPharmaSwiss  Česká republika s.r.o.EU-Listed(Origin:England) 
5-6地高辛片Digoxin Tablets/Lanoxin0.25mgtablet Concordia Pharmaceuticals IncOrange Book-USA
5-7多潘立酮片Domperidone Tablets/Motilium10mgtablet Janssen-Cilag (Val de Reuil) FranceEU-Listed(Listed Country:France;Origin:France)France Listed Name:Domperidone Film-coated Tablets
5-8奋乃静片Perphenazine Tablets/PERPHENAZINE2mgtabletSANDOZ INCOrange Book-USA
5-9奋乃静片Perphenazine Tablets/PERPHENAZINE4mgtabletSANDOZ INCOrange Book-USA
5-10复方地芬诺酯片Compound Diphenoxylate Hydrochloride Tablets/LomotilDiphenoxylate Hydrochloride 2.5mg,Diphenoxylate Hydrochloride 25μgtablet GD SEARLE LLCOrange Book-USAAmerica Listed Name:diphenoxylate hydrochloride
and atropine sulfate tablets
5-11格列本脲片Glibenclamide Tablets/Daonil2.5mgtabletsanofi K.K.Orange Book-Japan
5-12枸橼酸他莫昔芬片Tamoxifen Citrate Tablets/Nolvadex10mg(On the Basis of  tamoxifen)tabletAstrazeneca K.K.Orange Book-Japan
5-13红霉素肠溶胶囊Erythromycin Enteric Capsules/ERYC0.25g(250000 units)CapsuleMayne Pharma International Pty LtdOrange Book-USAAmerica Listed Name:Erythromycin delayed-release capsules
5-14红霉素Enteric-coated TabletsErythromycin Enteric-coated Tablets/ERY-TAB0.25g(250000 units)tablet Arbor Pharmaceuticals LLCOrange Book-USAAmerica Listed Name:Erythromycin delayed-release tablets
5-15琥珀酸亚铁片Ferrous Succinate Tablets/INOFER0.1gtablet LABORATOIRE DE L’ INOFEREU-Listed(Listed Country:France;Origin:France)
5-16华法林钠片Warfarin Sodium Tablets/Coumadin2.5mgtabletBristol Myers Squibb Pharma CoOrange Book-USA
5-17华法林钠片Warfarin Sodium Tablets/Coumadin5mgtabletBristol Myers Squibb Pharma CoOrange Book-USA
5-18己烯雌酚片Diethylstilbestrol Tablets /DISTILBENE1mgtabletLABORATOIRES GERDAEU-Listed(Listed Country:France;Origin:France)
5-19卡托普利片Captopril Tablets/CAPTORIL 12.5mgtabletDaiichi Sankyo Espha Co.,  Ltd.Orange Book-Japan
5-20卡托普利片Captopril Tablets/CAPTORIL 25mgtabletDaiichi Sankyo Espha Co.,  Ltd.Orange Book-Japan
5-21利培酮片Risperidone Tablets/Risperdal1mgtabletJanssen Pharmaceuticals IncOrange Book-USA
5-22利培酮片Risperidone Tablets/Risperdal2mgtabletJanssen Pharmaceuticals IncOrange Book-USA
5-23柳氮磺吡啶Enteric-coated TabletsSulfasalazine Enteric-coated Tablets/Azulfidine0.25gtablet(Enteric-coated Tablets)Pfizer Japan Inc.Orange Book-JapanJapan Listed NameSalazosulfapyridine Enteric-coated Tablets
5-24马来酸多潘立酮片Domperidone Maleate Tablets/Motilium10mg(On the Basis of  C22H24ClN5O2)tablet Johnson & Johnson Consumer N.V./S.A.-BelgiumEU-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/CAFERGOTErgotamine Tartrate 1mg,Anhydrous Caffeine 100mgtabletSANDOZ INCOrange Book-USAAmerica Listed Name:Ergotamine Tartrate and Caffeine Tablets
5-26蒙脱石散Montmorillonite Powder/SMECTA3gPowdersIPSEN PHARMAEU-Listed(Listed Country:France;Origin:France)
5-27米非司酮片 Mifepristone Tablets/Mifegyne0.2gtabletEXELGYNEU-Listed(Listed Country:France;Origin:France)
5-28诺氟沙星片Norfloxacin Tablets/BACCIDAL0.1gtabletKYORIN Pharmaceutical Co.,Ltd.Orange Book-Japan
5-29氢化可的松片Hydrocortisone Tablets/Cortef10mgtablet PHARMACIA AND UPJOHN COOrange Book-USA
5-30氢化可的松片Hydrocortisone Tablets/Cortef20mgtablet PHARMACIA AND UPJOHN COOrange Book-USA
5-31舒必利片Sulpiride Tablets/Abilit0.1gtablet Dainippon Sumitomo Pharma Co., Ltd.Orange Book-Japan
5-32舒必利片Sulpiride Tablets/Abilit50mgtablet Dainippon Sumitomo Pharma Co., Ltd.Orange Book-Japan
5-33替加氟胶囊Tegafur Capsules/Futraful0.2gCapsuleTAIHO PHARMACEUTICAL CO., LTD.Orange Book-Japan
5-34替硝唑片Tinidazole Tablets/Fasigyn0.5gtabletPfizer LimitedEU-Listed(Listed Country:England;Origin:France)
5-35硝酸异山梨酯片Isosorbide Dinitrate Tablets/ISORDIL5mgtablet VALEANT PHARMACEUTICALS NORTH AMERICA LLCOrange Book-USA
5-36盐酸地尔硫䓬片Diltiazem  Hydrochloride  Tablets/ HERBESSER30mgtabletMitsubishi Tanabe Pharma CorporationOrange Book-Japan
5-37盐酸二甲双胍片Metformin Hydrochloride Tablets/Glycoran0.25gtabletNIPPON SHINYAKU CO.,LTD.Orange Book-Japan
5-38盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.5gtabletMerck  Santé S.A.SEU-Listed(Listed Country:France;Origin:France)
5-39盐酸雷尼替丁胶囊Ranitidine Hydrochloride Capsules/RANITIDINE HYDROCHLORIDE0.15g(On the Basis of  C13H22N403S)CapsuleSANDOZ INCOrange Book-USA
5-40盐酸雷尼替丁片Ranitidine Hydrochloride Tablets/Zantac0.15g(On the Basis of  C13H22N403S)tabletGlaxo SmithKline UKEU-Listed:(Listed Country:England;Origin:Germany)
5-41盐酸美西律片Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride50mgtabletKYOWA CritiCare Co., LtdOrange Book-Japan
5-42盐酸美西律片Mexiletine Hydrochloride Tablets/Mexiletine Hydrochloride0.1gtabletKYOWA CritiCare Co., LtdOrange Book-Japan
5-43盐酸帕罗西汀片Paroxetine Hydrochloride/Paxil20mg(On the Basis of  C19H20FNO3)tabletApotex Technologies IncOrange Book-USA
5-44盐酸乙胺丁醇片Ethambutol Hydrochloride Tables/Ebutol0.25gtabletKaken Pharmaceutical Co.,Ltd.Orange Book-Japan
5-45异烟肼片Isoniazid Tablets/Isoniazid0.3gtabletSANDOZ INCOrange Book-USA
5-46异烟肼片Isoniazid Tablets/Isoniazid0.1gtabletSANDOZ INCOrange Book-USA
5-47盐酸普萘洛尔片Propranolol Hydrochloride Tablets/Inderal10mgtablet AstraZeneca K.K.Orange Book-Japan
5-48丙硫氧嘧啶片Propylthiouracil Tablets/PROPYL-THYRACIL0.1gtabletPaladin Labs IncListed Country:Canada
5-49磷酸氯喹片Chloroquine Phosphate   Tablets/Resochin0.25g(On the Basis of  Chloroquine C18H26ClN3155mg)tabletBayer Vital GmbHEU-Listed(Listed Country:Germany;Origin:Germany








List of Generic Reference Preparations (6th batch) 








No.Generic NameEnglish Name/Proprietary NameStrengthDosage FormApplicant HolderNote1Note2
6月1日草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro5mg(On the Basis of  C20H21FN2O)tabletH. Lundbeck A/SOriginal Import
6月2日草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro10mg(On the Basis of  C20H21FN2O)tabletH. Lundbeck A/SOriginal Import
6月3日草酸艾司西酞普兰片Escitalopram Oxalate Tablets/Lexapro20mg(On the Basis of  C20H21FN2O)tabletH. Lundbeck A/SOriginal Import
6月4日多潘立酮口崩片Domperidone Orally Disintegrating Tablets/Motilium10mgtabletJanssen-Cilag AG - SwitzerlandEU-Listed ( Listed Country:Switzerland;Origin:England)Switzerland Listed Name:Domperidone Orodispersible Tablets
6月5日恩替卡韦片Entecavir Tablets /BARACLUDE0.5mgtabletBRISTOL MYERS SQUIBBOrange Book-USA
6月6日恩替卡韦片Entecavir Tablets /BARACLUDE1mgtabletBRISTOL MYERS SQUIBBOrange Book-USA
6月7日红霉素Erythromycin Enteric-coated Tablets/ERY-TAB0.5g(500000 units)tabletArbor Pharmaceuticals LLCOrange Book-USAAmerica Listed Name:Erythromycin delayed-release tablets
6月8日甲磺酸倍他司汀片Betahistine Mesilate Tablets/Merislon6mgtabletEisai Co., Ltd.Orange Book-Japan
6月9日利培酮片Risperidone Tablets/Risperdal3mgtabletJanssen Pharmaceuticals IncOrange Book-USA
6月10日磷酸奥司他韦胶囊 Oseltamivir  Phosphate Capsules/ Tamiflu75mg(On the Basis of  C16H28N2O4)CapsuleRoche Registration Ltd.Original Import
6月11日硫酸氨基葡萄糖胶囊Glucosamine Sulfate Capsules/Viartril-S0.25g(On the Basis of Glucosamine sulfate)CapsuleROTTAPHARM S.P.AOriginal Import Applicable to: glucosamine sulfate mixture containing sodium chloride 
6月12日硫酸羟氯喹片 Hydroxychloroquine Sulfate Tablets/Plaquenil0.2gtabletAventis Pharma LimitedOriginal Import
6月13日匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa1mgtablet Kowa Company, Ltd.Original Import
6月14日匹伐他汀钙片Pitavastatin CalciumTablets /Livalo Kowa2mgtablet Kowa Company, Ltd.Original Import
6月15日氢溴酸西酞普兰片Citalopram Hydrobromide Tablets/Cipramil20mg(On the Basis of  C20H21FN2O)tabletH. Lundbeck A/SOriginal Import
6月16日头孢地尼胶囊Cefdinir Capsules/Cefzon0.1gCapsuleAstellas Pharma Inc.Original Import
6月17日缬沙坦胶囊Valsartan Capsules/DIOVAN40mgCapsuleNovartis Pharmaceuticals UK LimitedEU-Listed(Listed Country:England;Origin:Switzerland)
6月18日缬沙坦胶囊Valsartan Capsules/DIOVAN0.16gCapsuleNovartis Pharmaceuticals UK LimitedEU-Listed(Listed Country:England;Origin:Switzerland)
6月19日缬沙坦片Valsartan Tablets/DIOVAN0.16gtabletNOVARTIS PHARMACEUTICALS CORPOrange Book-USA
6月20日缬沙坦片Valsartan Tablets/DIOVAN80mgtabletNOVARTIS PHARMACEUTICALS CORPOrange Book-USA
6月21日缬沙坦片Valsartan Tablets/DIOVAN40mgtabletNOVARTIS PHARMACEUTICALS CORPOrange Book-USA
6月22日盐酸
乙胺丁醇片
Ethambutol Hydrochloride Tablets/Myambutol0.4gtabletSTI Pharma LLCOrange Book-USA
6月23日盐酸地尔硫䓬片Diltiazem  Hydrochloride  Tablets/ HERBESSER60mgtabletMitsubishi Tanabe Pharma CorporationOrange Book-Japan
6月24日盐酸二甲双胍缓释片Metformin Hydrochloride Sustained-release Tablets/GLUCOPHAGE XR0.5gSustained Release TabletsBRISTOL MYERS SQUIBB COOrange Book-USA
6月25日盐酸二甲双胍片Metformin Hydrochloride Tablets/Glucophage0.85gtabletMerck  Santé S.A.SEU-Listed(Listed Country:France;Origin:France)
6月26日盐酸雷尼替丁片Ranitidine Hydrochloride Tablets/Zantac 75mg(On the Basis of   C13H22N403S)tabletGlaxo SmithKline K.KOrange Book-Japan
6月27日盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil50mgCapsuleNippon Boehringer Ingelheim Co., Ltd.Orange Book-Japan
6月28日盐酸美西律胶囊Mexiletine Hydrochloride Capsules/Mexitil0.1gCapsuleNippon Boehringer Ingelheim Co., Ltd.Orange Book-Japan
6月29日盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.125g(On the Basis of  C21H25N)tabletSun Pharmaceutical Industries LimitedOrange Book-Japan
6月30日盐酸特比萘芬片Terbinafine Hydrochloride Tablets/Lamisil0.25g(On the Basis of  C21H25N)tabletNOVARTIS PHARMACEUTICALS   CORPOrange Book-USA
6-31盐酸西替利嗪口崩片Cetirizine Hydrochloride Orally10mgtablet(Orally Disintegrating Tablet)Johnson and Johnson Consumer Inc Mcneil Consumer Healthcare DivisionOrange Book-USA
Disintegrating Tablets/Zyrtec Allergy
6-32盐酸西替利嗪片Cetirizine Hydrochloride Tablets/Zyrtec10mgtabletUCB-Pharma AGOriginal Import
6-33盐酸左西替利嗪片Levocetirizine Hydrochloride Tablets/Xyzal5mgtabletUCB Pharma AGOriginal Import
6-34硬脂酸红霉素片Erythromycin Stearate   Tablets/ERYTHROCIN STEARATE0.25g(On the Basis of  C37H67NO13,250000 units)tabletArbor Pharmaceuticals LLCOrange Book-USA
6-35阿司匹林肠溶胶囊Aspirin Enteric Capsules/Astrix0.1gCapsule(Enteric Capsule)Mayne Pharma International Pty LtdListed Country:Australia


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