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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2500062 甘精胰岛素利司那肽注射液(Ⅰ) insulin glargine;lixisenatide Injection Biological Products(3.4) New Drug Application 2025-06-11 Sanofi (Beijing) Pharmaceuticals Co Ltd view
CXSS2500063 甘精胰岛素利司那肽注射液(Ⅱ) insulin glargine;lixisenatide Injection Biological Products(3.4) New Drug Application 2025-06-11 Sanofi (Beijing) Pharmaceuticals Co Ltd view
CYSB2500085 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2025-04-18 Gan & Lee Pharmaceuticals view
CYSB2500086 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2025-04-18 Gan & Lee Pharmaceuticals view
CXSL2500306 甘精胰岛素注射液 insulin glargine Injection Biological Products(3.3) New Drug Application 2025-04-16 Yifan Pharmaceutical (Shanghai) Co Ltd view
CYSB2500009 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2025-01-09 Gan & Lee Pharmaceuticals view
CYSB2500008 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2025-01-09 Gan & Lee Pharmaceuticals view
CYSB2400321 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-12-11 Gan & Lee Pharmaceuticals;Gan&Lee Pharmaceuticals Shandong Co Ltd view
JYSB2400242 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-11-23 Sanofi-Aventis Deutschland GmbH view
JYSB2400241 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-11-23 Sanofi-Aventis Deutschland GmbH view
CYSB2400236 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-09-13 Zhuhai United Laboratories Co Ltd view
CYSB2400237 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-09-13 Zhuhai United Laboratories Co Ltd view
JYSZ2400051 甘精胰岛素注射液 insulin glargine Injection Biological Products License Renew 2024-09-04 Sanofi-Aventis Deutschland GmbH;Sanofi (Beijing) Pharmaceuticals Co Ltd view
CYSB2400224 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-08-29 Gan & Lee Pharmaceuticals view
JYSB2400174 甘精胰岛素利司那肽注射液(Ⅱ) insulin glargine;lixisenatide Injection Biological Products Supplementary Application 2024-08-09 Sanofi-Aventis Deutschland GmbH;Sanofi Winthrop Industrie view
JYSB2400173 甘精胰岛素利司那肽注射液(Ⅰ) insulin glargine;lixisenatide Injection Biological Products Supplementary Application 2024-08-09 Sanofi KK;Sanofi-Aventis Deutschland GmbH view
CYSB2400146 甘精胰岛素注射液 insulin glargine Injection Biological Products(3.3) Supplementary Application 2024-06-06 Yichang HEC Changjiang Pharmaceutical Co Ltd view
CYSB2400140 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-06-01 Gan & Lee Pharmaceuticals view
CYSB2400141 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-06-01 Gan & Lee Pharmaceuticals view
CYSB2400113 甘精胰岛素注射液 insulin glargine Injection Biological Products(3.3) Supplementary Application 2024-05-14 Fosun Wanbang (Jiangsu) Pharmaceutical Group Co Ltd view