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The 48th Batch of Reference Listed Drugs

No.	Product Name	Brand Name	Strength	MAH	Note 1	Note 2
48-1	Trazodone Hydrochloride Sustained-release Tablets	Trittico	75mg	AZ. Chim.Riun.Angelini Francesco Acraf S.P.A.	Original drug sold in China	Original drug imported to China
48-2	Topiramate Capsules	妥泰	15mg	Janssen-Cilag AG	Original drug sold in China	Original drug imported to China
48-3	Topiramate Capsules	妥泰	25mg	Janssen-Cilag AG	Original drug sold in China	Original drug imported to China
48-4	Miconazole Nitrate Cream and Suppositories	Monistat 3 Combination Pack	2%，200mg	Medtech Products Inc	Original drug not imported to China	US Orange Book
48-5	Pyridostigmine Bromide Syrup(oral solution)	Mestinon	60mg/5ml	Bausch Health US LLC	Original drug not imported to China	US Orange Book
48-6	Mitoxantrone Hydrochloride Injection		15ml:30mg	Hospira Worldwide, Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
48-7	Mitoxantrone Hydrochloride Injection		10ml:20mg	Hospira Worldwide, Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
48-8	Mitoxantrone Hydrochloride Injection		12.5ml：25mg	Hospira Worldwide, Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
48-9	Hydrocortisone Butyrate Cream	Locoid	0.10%	Leo Pharma A/S / Cheplapharm Arzneimittel Gmbh	Original drug not imported to China	Sold in the EU
48-10	Lidocaine and Prilocaine Patch	Emla Pflaster	Each tablet contains 1g of emulsion (lidocaine 25mg, prilocaine 25mg)	Aspen Pharma Trading Limited	Original drug not imported to China	Sold in the EU
48-11	Metoclopramide Hydrochloride Injection		10mg/2ml	Sanofi-Aventis France	Original drug not imported to China	Sold in the EU
48-12	Tosufloxacin Tosilate ophthalmic solution	Ozex	0.30%	富士フイルム富山化学工業株式会社	Original drug not imported to China	Sold in Japan
48-13	Ketotifen Fumarate Nasal Spray	Zaditen	0.05%	サンファーマ株式会社	Original drug not imported to China	Sold in Japan
48-14	Etizolam Tablets	Depas	0.25mg	Mitsubishi Tanabe Pharma Corporation	Original drug not imported to China	Sold in Japan
48-15	Etizolam Tablets	Depas	0.5mg	Mitsubishi Tanabe Pharma Corporation	Original drug not imported to China	Sold in Japan
48-16	Etizolam Tablets	Depas	1mg	Mitsubishi Tanabe Pharma Corporation	Original drug not imported to China	Sold in Japan
48-17	Apalutamide Tablets	Erleada（安森珂）	60mg	Janssen-Cilag International NV	Original drug sold in China	Original drug imported to China
48-18	Iopromide Injection	Ultravist（优维显）	100ml:62.34g	Bayer Vital GmbH	Original drug sold in China	Original drug imported to China
48-19	Cytarabine for Injection	Cytosar（赛德萨）	0.1g	Pfizer Pharmaceutical(Wuxi)Co.,Ltd.	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
48-20	Cytarabine for Injection	Cytosar（赛德萨）	0.5g	Pfizer Pharmaceutical(Wuxi)Co.,Ltd.	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
48-21	Pemetrexed Disodium for Injection	Alimta	100mg	Eli Lilly and Company	Original drug not imported to China	US Orange Book
48-22	Pemetrexed Disodium for Injection	Alimta	500mg	Eli Lilly and Company	Original drug not imported to China	US Orange Book
48-23	Everolimus Tablets	Afinitor	2.5mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-24	Everolimus Tablets	Afinitor	5mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-25	Everolimus Tablets	Zortress	0.25mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-26	Everolimus Tablets	Zortress	0.5mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-27	Everolimus Tablets	Zortress	0.75mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-28	Everolimus Tablets	Zortress	1mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-29	Paliperidone Palmitate Extended-release Injectable Suspension	Invega Trinza	273mg/0.875ml	Janssen Pharmaceuticals, Inc.	Original drug not imported to China	US Orange Book
48-30	Paliperidone Palmitate Extended-release Injectable Suspension	Invega Trinza	410mg/1.315ml	Janssen Pharmaceuticals, Inc.	Original drug not imported to China	US Orange Book
48-31	Paliperidone Palmitate Extended-release Injectable Suspension	Invega Trinza	546mg/1.75ml	Janssen Pharmaceuticals, Inc.	Original drug not imported to China	US Orange Book
48-32	Paliperidone Palmitate Extended-release Injectable Suspension	Invega Trinza	819mg/2.625ml	Janssen Pharmaceuticals, Inc.	Original drug not imported to China	US Orange Book
48-33	Valsartan and Hydrochlorothiazide Tablets	Diovan Hct	Each tablet contains valsartan 160mg, hydrochlorothiazide 12.5mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-34	Valsartan and Hydrochlorothiazide Tablets	Diovan Hct	Each tablet contains valsartan 160mg, hydrochlorothiazide 25mg	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
48-35	Medroxyprogesterone Acetate Tablets		2.5mg	Pharmacia and Upjohn Co.	Original drug not imported to China	US Orange Book
48-36	Medroxyprogesterone Acetate Tablets		5mg	Pharmacia and Upjohn Co.	Original drug not imported to China	US Orange Book
48-37	Calcium Acetate Tablets		0.667g	Chartwell Molecular Holdings Llc	Internationally recognized to be equivalent to the original drug	US Orange Book
48-38	Vitamin K1 Injection		0.5ml:1mg	Hospira Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
48-39	Letrozole Tablets	Femara	2.5mg	Novartis Pharma S.A.S.	Original drug not imported to China	Sold in the EU
48-40	Xeplion 25 mg Prolonged Release Suspension For Injection		25mg	Janssen-Cilag International N.V.	Original drug not imported to China	Sold in the EU
48-41	Xeplion 50 mg Prolonged Release Suspension For Injection		50mg	Janssen-Cilag International N.V.	Original drug not imported to China	Sold in the EU
48-42	Xeplion 75 mg Prolonged Release Suspension For Injection		75mg	Janssen-Cilag International N.V.	Original drug not imported to China	Sold in the EU
48-43	Xeplion 100 mg Prolonged Release Suspension For Injection		100mg	Janssen-Cilag International N.V.	Original drug not imported to China	Sold in the EU
48-44	Xeplion 150 mg Prolonged Release Suspension For Injection		150mg	Janssen-Cilag International N.V.	Original drug not imported to China	Sold in the EU
48-45	Trevicta 175 mg Prolonged Release Suspension For Injection		175mg	Janssen-Cilag International NV	Original drug not imported to China	Sold in the EU
48-46	Trevicta 263 mg Prolonged Release Suspension For Injection		263mg	Janssen-Cilag International NV	Original drug not imported to China	Sold in the EU
48-47	Trevicta 350 mg Prolonged Release Suspension For Injection		350mg	Janssen-Cilag International NV	Original drug not imported to China	Sold in the EU
48-48	Trevicta 525 mg Prolonged Release Suspension For Injection		525mg	Janssen-Cilag International NV	Original drug not imported to China	Sold in the EU
48-49	Mesalazine Gastro-Resistant Prolonged-Release Granules	Salofalk	1g	Dr. Falk Pharma GmbH	Original drug not imported to China	Sold in the EU
48-50	Mesalazine Gastro-Resistant Prolonged-Release Granules	Salofalk	3g	Dr. Falk Pharma GmbH	Original drug not imported to China	Sold in the EU
48-51	Ondansetron Oral Soluble Film		4mg	Norgine Pharmaceuticals Limited	Original drug not imported to China	Sold in the EU
48-52	Ondansetron Oral Soluble Film		8mg	Norgine Pharmaceuticals Limited	Original drug not imported to China	Sold in the EU
48-53	Ketoconazole Cream	Nizoral 2% Creme	2%	Johnson & Johnson GmbH	Original drug not imported to China	Sold in the EU
48-54	Ropinirole Hydrochloride Tablets	Requip	0.25mg	グラクソ・スミスクライン株式会社	Original drug not imported to China	Sold in Japan
48-55	Lacosamide Injection	Vimpat	10ml:100mg	ユーシービージャパン株式会社	Original drug not imported to China	Sold in Japan
48-56	Lacosamide Injection	Vimpat	20ml:200mg	ユーシービージャパン株式会社	Original drug not imported to China	Sold in Japan
48-57	Cycloserine Capsules		250mg	Meiji Seikaファルマ株式会社	Internationally recognized to be equivalent to the original drug	Sold in Japan

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