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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2500629 JAB-8263片 JAB-8263 Tablet Chemical Drugs(1) New Drug Application 2025-07-01 Beijing Jiakesi New Drug Development Co Ltd view
CYHB2501297 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2025-07-01 Astrazeneca Pharmaceutical Co Ltd view
CYHS2502327 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs(4) Generic Drug 2025-07-01 Jiangsu Vanguard Pharmaceutical Co Ltd view
CYHB2501289 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(4) Supplementary Application 2025-07-01 QILU Pharmaceutical Co Ltd view
CYZB2501348 肾炎片 Tablet Chinese Herbal Medicine Supplementary Application 2025-07-01 Shaanxi Kanghui Pharmaceutical Co Ltd view
CYHB2501293 尼麦角林注射液 nicergoline Injection Chemical Drugs Supplementary Application 2025-07-01 Hainan Fengkai Si Pharmaceutical Co Ltd;Hainan Lingkang Pharmaceutical Co Ltd view
CYHB2550243 多索茶碱片 doxofylline Tablet Chemical Drugs Supplementary Application 2025-07-01 Xinxiang Changle Pharmaceutical Co Ltd;Haimen PHARMA INC view
CYHS2502329 磷酸奥司他韦胶囊 oseltamivir phosphate Capsule Chemical Drugs(4) Generic Drug 2025-07-01 Jiangsu Vanguard Pharmaceutical Co Ltd view
CYZB2501340 雪山金罗汉止痛涂膜剂 Film Chinese Herbal Medicine(原3) Supplementary Application 2025-07-01 Tibet Rhodiola Pharmaceutical Holding Co view
CYSB2500141 昂戈瑞西单抗注射液 ongericimab Injection Biological Products(1) Supplementary Application 2025-07-01 Shanghai Jun Shi Biological Engineering Technology Co Ltd;Chongqing Bochuang Pharmaceutical Co Ltd view
CYSB2500145 斯鲁利单抗注射液 Serplulimab Injection Biological Products Supplementary Application 2025-07-01 Shanghai Fuhong Ruilin Biotechnology Co Ltd;Shanghai Henlius Biopharmaceutical Co Ltd view
CXSL2500524 9MW4611注射液 Biological Products(1) New Drug Application 2025-07-01 Mabwell (Shanghai) Bioscience Co Ltd view
CYZB2501341 苏子油软胶囊 Soft capsules Chinese Herbal Medicine Supplementary Application 2025-07-01 Jinhao Pharmaceutical (Shandong) Co Ltd view
CYHS2502326 硫酸特布他林口服溶液 terbutaline sulfate Oral solution Chemical Drugs(3) Generic Drug 2025-07-01 Jiangsu Omega Pharmaceutical Co Ltd;Zhengzhou Daruo Pharmaceutical Technology Co Ltd view
CYSB2500143 注射用伊尼妥单抗 Inetetamab Lyophilized Biological Products Supplementary Application 2025-07-01 Sunshine Guojian Pharmaceutical(Shanghai) Co Ltd view
CYHB2501286 吸入用复方异丙托溴铵溶液 ipratropium bromide;salbutamol sulfate Inhalation Chemical Drugs(4) Supplementary Application 2025-07-01 Weifang Zhongshi Pharmaceutical Co Ltd;Jinan Jingsheng Technology Co Ltd view
CYZB2501349 冠心丹参胶囊 Capsule Chinese Herbal Medicine(4) Supplementary Application 2025-07-01 Inner Mongolia Baotou Traditional Chinese Medicine Co Ltd view
CYHB2501288 乙磺酸尼达尼布软胶囊 nintedanib esylate Soft capsules Chemical Drugs(4) Supplementary Application 2025-07-01 QILU Pharmaceutical Co Ltd view
CYZB2501346 心可宁胶囊 Capsule Chinese Herbal Medicine(原9) Supplementary Application 2025-07-01 Topfond Pharmaceutical Co Ltd;Henan Tianfang Pharmaceutical Co Ltd view
CYHB2501291 复方电解质葡萄糖注射液-R4A Injection Chemical Drugs Supplementary Application 2025-07-01 Sichuan Kelun Pharmaceutical Co Ltd;Beijing Yuanyuan Tongda Pharmaceutical Technology Co Ltd view