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The 38th Batch of Reference Listed Drugs

No.	Product Name	Brand Name	Strength	MAH	Note 1	Note 2
38-1	Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray	Spiolto（思合华）	60 Sprays per vial. Each actuation from the STIOLTO RESPIMAT inhaler delivers 2.5 mcg tiotropium (equivalent to 3.124 mcg tiotropium bromide monohydrate) and 2.5 mcg olodaterol (equivalent to 2.736 mcg olodaterol hydrochloride) from the mouthpiece.	Boehringer Ingelheim International GmbH	Original drug sold in China	Original drug imported to China
38-2	Tiotropium Bromide Spray	-	2.5μg	Boehringer Ingelheim International GmbH	Original drug sold in China	Original drug imported to China
38-3	Miconazole Nitrate Vaginal Soft Capsules	Gyno-Daktarin（达克宁）	0.4g	Janssen-Cilag N.V.	Original drug sold in China	Original drug imported to China
38-4	Miconazole Nitrate Vaginal Soft Capsules	Gyno-Daktarin（达克宁）	1.2g	Janssen-Cilag N.V.	Original drug sold in China	Original drug imported to China
38-5	Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets		Buprenorphine 2 mg / naloxone 0.5 mg	Indivior UK Limited	Original drug sold in China	Original drug imported to China
38-6	Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets		Buprenorphine 8 mg / naloxone 2 mg	Indivior UK Limited	Original drug sold in China	Original drug imported to China
38-7	Carboxymethylcellulose Sodium Eye Drops	-	0.4ml:2mg	Allergan Pharmaceuticals Ireland	Original drug sold in China	Original drug imported to China
38-8	Compound Betamethasone Injection	得宝松	1ml: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg	MSD Merck Sharp & Dohme AG	Original drug sold in China	Original drug imported to China
38-9	Perflubutane Microspheres for Injection	Sonazoid（示卓安）	16μl	GE Healthcare AS	Original drug sold in China	Original drug imported to China
38-10	Sofosbuvir，Velpatasvir and Voxilaprevir tablets	Vosevi（沃士韦）	Each tablet contains 400mg sofosbuvir, 100mg velpatasvir and 100mg vociprevir	Gilead Sciences Ireland UC	Original drug sold in China	Original drug imported to China
38-11	Vitamin Complex Tablets	Elevit Pronatal（爱乐维）	compound	Bayer S.A.	Original drug sold in China	Original drug imported to China
38-12	Olopatadine Hydrochloride Nasal Spray	Patanase	0.665mg/spray	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
38-13	Ciprofloxacin Ophthalmic Solution	Ciloxan	0.30%	Novartis Pharmaceuticals Corp	Original drug not imported to China	US Orange Book
38-14	Ephedrine Sulfate Injection	Akovaz	50mg/ml	Exela Pharma Sciences LLC	Original drug not imported to China	US Orange Book
38-15	Icodextrin Peritoneal Dialysis Solution	Extraneal	7.5% (2L/package、2.5L/package）	Baxter Healthcare Corporation	Original drug not imported to China	US Orange Book
38-16	Icodextrin Peritoneal Dialysis Solution	Extraneal	7.5% (1.5L/package、2L/package、2.5L/package）	Baxter A/S	Original drug not imported to China	Sold in the EU
38-17	Amino Acids （15） Peritoneal Dialysis Solution	-	2.0L	Baxter Healthcare Ltd.	Original drug not imported to China	Sold in the EU
38-18	Amino Acids （15） Peritoneal Dialysis Solution	-	2.5L	Baxter Healthcare Ltd.	Original drug not imported to China	Sold in the EU
38-19	Ferric Maltol Capsules	Feraccru	30mg	Norgine B.V.	Original drug not imported to China	Sold in the EU
38-20	Lormetazepam Injection	Sedalam	10ml：2mg	Dr. Franz Köhler Chemie GmbH	Original drug not imported to China	Sold in the EU
38-21	Isoconazole Nitrate Vaginal Tablets	-	300mg	バイエル薬品株式会社	Original drug not imported to China	Sold in Japan
38-22	Cefcapene Pivoxil Hydrochloride Tablet	Flomox	100mg	塩野義製薬株式会社	Original drug not imported to China	Sold in Japan
38-23	Ofloxacin Ear Drops	-	0.30%	アルフレッサファーマ株式会社/第一三共株式会社	Original drug not imported to China	Sold in Japan
38-24	Falecalcitriol Tablets	Fulstan	0.15μg	大日本住友製薬株式会社	Original drug not imported to China	Sold in Japan
38-25	Falecalcitriol Tablets	Fulstan	0.3μg	大日本住友製薬株式会社	Original drug not imported to China	Sold in Japan
38-26	Pirarubicin Hydrochloride for Injection	Pinorubin	10mg	日本マイクロバイオファーマ株式会社	Original drug not imported to China	Sold in Japan
38-27	Pirarubicin Hydrochloride for Injection	Pinorubin	20mg	日本マイクロバイオファーマ株式会社	Original drug not imported to China	Sold in Japan
38-28	Pirarubicin Hydrochloride for Injection	Pinorubin	30mg	日本マイクロバイオファーマ株式会社	Original drug not imported to China	Sold in Japan
38-29	Doxorubicin Hydrochloride for Injection	Adriacin	10mg	アスペンジャパン株式会社	Original drug not imported to China	Sold in Japan
38-30	Mesalazine Sustained-release Granules	Pentasa	1g	Ferring S.A.S	Original drug not imported to China	Sold in France
38-31	Mesalazine Sustained-release Granules	Pentasa	2g	Ferring S.A.S	Original drug not imported to China	Sold in France
38-32	Vonoprazan Fumarate Tablets	Vocinti（沃克）	10mg	Takeda Pharmaceutical Company Limited	Original drug sold in China	Original drug imported to China
38-33	Vonoprazan Fumarate Tablets	Vocinti（沃克）	20mg	Takeda Pharmaceutical Company Limited	Original drug sold in China	Original drug imported to China
38-34	Lanthanum Carbonate Oral Powder	Fosrenol	1000mg	Shire Development LLC/Takeda Pharmmaceuticals USA INC	Original drug not imported to China	US Orange Book
38-35	Nimodipine Oral Solution	Nymalize	6mg/ml	Arbor Pharmaceuticals, LLC	Original drug not imported to China	US Orange Book
38-36	Fluorouracil Injection	Fluorouracil	500mg/10ml	Accord Healthcare, Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
38-37	10% Amino Acid Injection	Trophamine 10%	10%（500ml）	B Braun Medical Inc	Original drug not imported to China	US Orange Book
38-38	Potassium Chloride Extended Release Tablets	K-Tab	20mEq	Abbvie Inc	Original drug not imported to China	US Orange Book
38-39	Pioglitazone Hydrochloride Tablets	Actos	45mg	Takeda Pharmaceuticals USA Inc	Original drug not imported to China	US Orange Book
38-40	Buspirone Hydrochloride Tablet	-	15mg	Teva Pharmaceuticals USA Inc.	Internationally recognized to be equivalent to the original drug	US Orange Book
38-41	Ropinirole Hydrochloride Sustained-release Tablets	-	8mg	GLAXO SMITHKLINE/SmithKline Beecham Limited	Original drug not imported to China	Sold in the EU
38-42	Calcium Folinate Injection	-	5ml：50mg	Hospira UK Ltd	Original drug not imported to China	Sold in the EU
38-43	Amlodipine Besylate Tablets	-	10mg	Pfizer	Original drug not imported to China	Sold in the EU
38-44	Methotrexate Injection	-	2ml：50mg	Pfizer Pharma Pfe GmbH	Original drug not imported to China	Sold in the EU
38-45	Docetaxel Injection	Taxotere	20mg/1ml	Sanofi Mature IP	Original drug not imported to China	Sold in the EU
38-46	Ropivacaine Hydrochloride Injection	Naropin/Naropeine/Naropina	20mg/10ml	Aspen Pharma Trading Limited	Original drug not imported to China	Sold in the EU
38-47	Tamsulosin Hydrochloride Oral Dispersible Sustained Release Tablets	-	0.2mg	Astellas Pharma Inc/アステラス製薬株式会社	Original drug not imported to China	Sold in Japan
38-48	Gadoteridol Injection	ProHance	10ml:2.793g	ブラッコスイス株式会社	Original drug not imported to China	Sold in Japan
38-49	Gadoteridol Injection	ProHance	15ml:4.1895g	ブラッコスイス株式会社	Original drug not imported to China	Sold in Japan
38-50	Ceftazidime For Injection	Modacin	1.0g	グラクソ・スミスクライン株式会社	Original drug not imported to China	Sold in Japan
38-51	Aztreonam For Injection	-	1.0g	日本エーザイ株式会社	Original drug not imported to China	Sold in Japan

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