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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHB2500118 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2025-08-30 Janssen Research & Development LLC;Janssen-Cilag SpA view
JXHB2500068 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2025-05-21 Janssen Research & Development LLC;Janssen-Cilag SpA view
JXHL2400229 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2024-09-25 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXHL2400207 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2024-08-26 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXHB2300183 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2023-12-07 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHL2300284 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2023-11-15 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JTH2300238 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs Disposable Import Drug Application 2023-10-10 Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV;Janssen-Cilag SpA view
JXHB2300062 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2023-04-10 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHB2300056 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2023-03-24 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHB2300019 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2023-01-20 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHB2200179 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2022-12-10 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHL2200296 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2022-10-01 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXHB2200126 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2022-09-07 Janssen-Cilag International NV;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHL2200269 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2022-09-01 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXHB2200087 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Supplementary Application 2022-07-05 Janssen Research & Development LLC;Janssen-Cilag SpA;Patheon Pharmaceuticals Inc view
JXHL2200157 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2022-06-21 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXHL2101140 Lazertinib片 lazertinib mesylate Tablet Chemical Drugs(2.4) Import Drug Application 2021-07-26 Janssen-Cilag International NV;Johnson & Johnson (CHINA) Investment Ltd view