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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSL2500113 VAY736注射液 ianalumab Injection Biological Products(1) Import Drug Application 2025-06-28 China Novartis Institutes For Biomedical Research Co Ltd;Novartis Pharma Schweiz AG view
CYHS2502253 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Generic Drug 2025-06-23 Kunming Yuanrui Pharmaceutical Co Ltd view
CYHS2502287 盐酸丙卡特罗颗粒 procaterol hydrochloride Granule Chemical Drugs(3) Generic Drug 2025-06-26 Guangzhou Poinsettia Pharmaceutical Co Ltd view
CYZB2501271 三子散 Powder Chinese Herbal Medicine Supplementary Application 2025-06-24 INNER MONGOLIA Mongolian MEDICINE Co Ltd view
CYHB2501272 异烟肼片 isoniazid Tablet Chemical Drugs Supplementary Application 2025-06-28 Heilongjiang Haxing Pharmaceutical Co Ltd;Heilongjiang Jun'an Pharmaceutical Group Hongxiang Pharmaceutical Co Ltd view
JYHZ2500123 阿奇霉素片 azithromycin Tablet Chemical Drugs(5.1) License Renew 2025-06-25 Pliva Croatia Ltd;Teva Pharmaceutical Information Consulting (Shanghai) Co Ltd view
CYHB2501264 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Supplementary Application 2025-06-27 Zhejiang Cdmo Pharmaceutical Co Ltd;Suzhou No3 Pharmaceutical Factory Co Ltd view
CXHL2500619 戊二酸利那拉生酯胶囊 linaprazan glurate Capsule Chemical Drugs(2.4) New Drug Application 2025-06-26 Shanghai Shengnuo Pharmaceutical Technology Co Ltd view
CXHL2500606 JMKX003002片 JMKX-003002 Tablet Chemical Drugs(1) New Drug Application 2025-06-23 Zhejiang Hangyu Pharmaceutical Co Ltd view
CYZB2501264 复方片仔癀软膏 Ointment Chinese Herbal Medicine Supplementary Application 2025-06-24 Zhangzhou Pientzehuang Pharmaceutical Co Ltd view
CYHS2502310 甲磺酸溴隐亭片 bromocriptine mesylate Tablet Chemical Drugs(4) Generic Drug 2025-06-28 Hunan Zhengtai Jinhu Pharmaceutical Co Ltd view
JYSB2500152 仑卡奈单抗注射液 lecanemab Injection Biological Products(1) Supplementary Application 2025-06-27 Biogen US Corp;Eisai Inc view
CYZB2501327 杜仲平压片 Tablet Chinese Herbal Medicine(原9) Supplementary Application 2025-06-28 Shanxi Huakang Pharmaceuticals Co Ltd view
JYSB2500150 达妥昔单抗β注射液 dinutuximab beta Injection Biological Products Supplementary Application 2025-06-25 Patheon Italia SpA;Recordati Netherlands BV view
CXHL2500624 QLH12016胶囊 QLH-12016 Capsule Chemical Drugs(1) New Drug Application 2025-06-27 QILU Pharmaceutical Co Ltd view
CYHB2501252 土霉素片 oxytetracycline Tablet Chemical Drugs Supplementary Application 2025-06-26 Heilongjiang Haxing Pharmaceutical Co Ltd;Heilongjiang Jun'an Pharmaceutical Group Hongxiang Pharmaceutical Co Ltd view
CYZB2501250 护肝片 Tablet Chinese Herbal Medicine(原9) Supplementary Application 2025-06-23 Jiang Xihua Too Pharmaceutical Co Ltd view
JXSL2500111 PF-08046054 (注射用冻干粉针) PF-08046054 Biological Products(1) Import Drug Application 2025-06-24 Pfizer Inc;Pfizer Investment Co Ltd view
CYHB2501281 硫辛酸注射液 Injection Chemical Drugs(4) Supplementary Application 2025-06-28 Fuan Pharmaceutical Group Yantai Justaware Pharmaceutical Co Ltd view
CXHL2500616 Sonrotoclax薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) New Drug Application 2025-06-24 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view