Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

Task Type

Major Special Varieties

Sequence No.

Stock Code

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
JXSL2101043	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Import Drug Application	2021-06-22		Astellas Pharma Inc;Astellas Pharmaceutical (China) Co Ltd			view
JXSL2101042	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Import Drug Application	2021-06-22		Astellas Pharma Inc;Astellas Pharmaceutical (China) Co Ltd			view
JXSL2000222	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Import Drug Application	2020-12-14	安斯泰来制药（中国）有限公司	Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc	In Review	2020-12-10	view
JXSL2000221	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Import Drug Application	2020-12-14	安斯泰来制药（中国）有限公司	Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc	In Review	2020-12-10	view
JXSL2000174	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Import Drug Application	2020-10-10	安斯泰来制药（中国）有限公司	Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc	In Review	2020-10-09	view
JXSL2000173	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Import Drug Application	2020-10-10	安斯泰来制药（中国）有限公司	Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc	In Review	2020-10-09	view
JXSB2400080	注射用Enfortumab Vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Supplementary Application	2024-06-18		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2400079	注射用Enfortumab Vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Supplementary Application	2024-06-18		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300170	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-12-28		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300169	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-12-28		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300048	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-04-25		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300047	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-04-25		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300046	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-04-25		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300045	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2023-04-25		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300044	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Supplementary Application	2023-04-18		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2300043	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(3.1)	Supplementary Application	2023-04-18		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2200055	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-05-07		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2200054	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-05-07		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2200051	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-04-27		Baxter Oncology GmbH;Astellas Pharma Inc			view
JXSB2200050	注射用enfortumab vedotin	enfortumab vedotin	Lyophilized	Biological Products(2.2)	Supplementary Application	2022-04-27		Baxter Oncology GmbH;Astellas Pharma Inc			view