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The 63rd Batch of Reference Listed Drugs

No. Drug Name/ Brand Name Strength MAH Note 1 Note 2
63-1 Xylometazoline Hydrochloride Nasal Spray 10mL:10mg GSK Consumer Healthcare Schweiz AG Original drug sold in China Original drug imported to China
63-2 Tofacitinib Citrate Sustained-release Tablets/Xeljanz(尚杰) 11mg Pfizer Inc Original drug sold in China Original drug imported to China
63-3 Anhydrous Ethanol Injection/ABLYSINOL 99%(5ml) BELCHER PHARMACEUTICALS LLC Original drug not imported to China US Orange Book
63-4 Bempedoic Acid and Ezetimibe Tablets/NEXLIZET 180mg/10mg Esperion Therapeutics Original drug not imported to China US Orange Book
63-5 Flortaucipir F 18 injection/TAUVID 30ML(8.1-51mCi/ML); Avid Radiopharmaceuticals Inc Original drug not imported to China US Orange Book
63-6 Flortaucipir F 18 injection/TAUVID 50ML(8.1-51mCi/ML) Avid Radiopharmaceuticals Inc Original drug not imported to China US Orange Book
63-7 Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension/Maxitrol 5 mL in 8 mL bottle Novartis Pharmaceuticals Corporation/Imprimis Pharms USA Original drug not imported to China US Orange Book
63-8 Tretinoin Lotion/Altreno 0.05% Dow Pharmaceutical Sciences Original drug not imported to China US Orange Book
63-9 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER 20%(2000ml) BAXTER HLTHCARE Original drug not imported to China US Orange Book
63-10 Safinamidemesylate Tablets/XADAGO 50mg MDD US Operations LLC Original drug not imported to China US Orange Book
63-11 Safinamidemesylate Tablets/XADAGO 100mg MDD US Operations LLC Original drug not imported to China US Orange Book
63-12 Acetaminophen Injection 50ml:500mg(10mg/ml) B Braunmedical Inc Original drug not imported to China US Orange Book
63-13 Acetaminophen Injection 100ml:1g(10mg/ml) B Braunmedical Inc Original drug not imported to China US Orange Book
63-14 Gadoteridol Injection/ProHance 279.3mg/mL(1.3965 g/5mL) Bracco Diagnostics Inc Original drug not imported to China US Orange Book
63-15 Gadoteridol Injection/ProHance 279.3mg/mL(2.793 g/10mL) Bracco Diagnostics Inc Original drug not imported to China US Orange Book
63-16 Gadoteridol Injection/ProHance 279.3mg/mL(4.1895 g/15mL) Bracco Diagnostics Inc Original drug not imported to China US Orange Book
63-17 Gadoteridol Injection/ProHance 279.3mg/mL(5.586 g/20mL) Bracco Diagnostics Inc Original drug not imported to China US Orange Book
63-18 Gadoteridol Injection/ProHance 279.3mg/mL(13.965 g/50mL) Bracco Diagnostics Inc Original drug not imported to China US Orange Book
63-19 Amlodipine besylate and benazepril hydrochloride capsules/Lotrel amlodipine 2.5 mg/benazepril 10 mg Novartis Pharmaceuticals Corp. Original drug not imported to China US Orange Book
63-20 Guaifenesin extended-release bi-layer tablets/Mucinex 1200mg RB HEALTH US LLC Original drug not imported to China US Orange Book
63-21 Gadobenate Dimeglumine Injection/Multihance 5.290GM/10ML(529MG/ML) Bracco Diagnostics Inc. Original drug not imported to China US Orange Book
63-22 Ezetimibe rosuvastatin zinc hard capsule/Cholecomb 5mg/10mg Proterapia Hungary Ltd Original drug not imported to China Sold in the EU
63-23 Ezetimibe rosuvastatin zinc hard capsule/Cholecomb 10mg/10mg Proterapia Hungary Ltd Original drug not imported to China Sold in the EU
63-24 Ezetimibe rosuvastatin zinc hard capsule/Cholecomb 20mg/10mg Proterapia Hungary Ltd Original drug not imported to China Sold in the EU
63-25 aminolevulinic acid hydrochloride gel/AMELUZ 78mg/g Biofrontera Bioscience GmbH Original drug not imported to China Sold in the EU
63-26 Carbidopa and Levodopa Sustained-release Tablets/SINEMET LP 25mg/100mg ORGANON FRANCE Original drug not imported to China Sold in the EU
63-27 Pitavastatin Calcium Tablets 1mg Kowa Pharmaceutical Europe GmbH Original drug not imported to China Sold in the EU
63-28 Pitavastatin Calcium Tablets 2mg Kowa Pharmaceutical Europe GmbH Original drug not imported to China Sold in the EU
63-29 Pitavastatin Calcium Tablets 4mg Kowa Pharmaceutical Europe GmbH Original drug not imported to China Sold in the EU
63-30 Bisoprolol Fumarate Tablets/Concor 5mg Merck Original drug not imported to China Sold in the EU
63-31 Metoprolol Succinate Sustained-release Tablets 23.75mg Recordati Ireland Ltd Original drug not imported to China Sold in the EU
63-32 Metronidazole Gel/Rozex/Metrogel 0.75% GALDERMA INTERNATIONAL/Galderma Laboratorium GmbH/Galderma(UK.) Limited Original drug not imported to China Sold in the EU
63-33 Pemirolast Potassium Dry Syrup/Alegysal 0.50% 田辺三菱製薬株式会社 Original drug not imported to China Sold in Japan
63-34 Zinc Acetate Tablets/ノベルジン(NOBELZIN) 25mg ノーベルファーマ株式会社(Nobel Pharma Co., Ltd.) Original drug not imported to China Sold in Japan
63-35 Zinc Acetate Tablets/ノベルジン(NOBELZIN) 50mg ノーベルファーマ株式会社(Nobel Pharma Co., Ltd.) Original drug not imported to China Sold in Japan
63-36 Iobenguane I123 Injection/ミオMIBG-I123注射液 111MBq/1.5ml PDRファーマ株式会社 Original drug not imported to China Sold in Japan
63-37 Sodium Bicarbonate Ringer's Injection(Ⅰ)/BICARBON 500ml エイワイファーマ株式会社 Original drug not imported to China Sold in Japan
63-38 Povidone Iodine solution 10% ムンディファーマ株式会社 Original drug not imported to China Sold in Japan
63-39 Pioglitazone Hydrochloride Orally Disintegrating Tablets/ACTOS OD 30mg Teva Takeda Yakuhin Ltd.(武田テバ薬品株式会社) Original drug not imported to China Sold in Japan
63-40 Clindamycin Phosphate Injection/Dalacin S 4mL:600mg ファイザー株式会社 Original drug not imported to China Sold in Japan
63-41 Oxazepam Tablets/Sobril 15mg Pfizer AS Original drug not imported to China Sold in Norway
63-42 Esmolol Hydrochloride and Sodium Chloride Injection 50ml: Esmolol Hydrochloride 1g and Sodium Chloride 0.205g Shanghai Baxter Healthcare Co.,Ltd. Manufactured by the approved original foreign company in China Original drug locally manufactured in China