Drug Registration and Acceptance

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Active Ingredient

Acceptance No.

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Status Date

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Evaluation Conclusion

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Special Approval Varieties

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Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Active Ingredient	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CXSL1700163	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2018-03-09	开封制药（集团）有限公司	Kaifeng Pharmaceutical (GROUP) Co Ltd	Certificate Issued	2018-09-25	view
CXSL1700162	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2018-03-09	开封制药（集团）有限公司	Kaifeng Pharmaceutical (GROUP) Co Ltd	Certificate Issued	2018-09-25	view
CXSS2300045	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2023-06-21					view
CXSB2400122	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(2.4)	Supplementary Application	2024-10-13		Chengdu Rongsheng Pharmaceuticals Co Ltd			view
CXSL2300639	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(2.4)	New Drug Application	2023-09-21		Chengdu Rongsheng Pharmaceuticals Co Ltd			view
CXSS2101084	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2021-12-23					view
CXSL2300638	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(2.4)	New Drug Application	2023-09-21		Chengdu Rongsheng Pharmaceuticals Co Ltd			view
CXSS2101083	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2021-12-23					view
CXSS2300044	注射用重组人凝血因子Ⅷ-Fc融合蛋白	Recombinant Human Coagulation Factor VIII-Fc Fusion Protein	Lyophilized	Biological Products(1)	New Drug Application	2023-06-21					view