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
CYHB2400347	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs	Supplementary Application	2024-03-07		Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd			view
CYHB2200630	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs	Supplementary Application	2022-04-19		Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd			view
CYHB2102282	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	Supplementary Application	2021-12-10		Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd			view
CXHB2000126	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	Supplementary Application	2020-11-20	再鼎医药（上海）有限公司	Zai Lab (Shanghai) Co Ltd	In Review	2020-11-19	view
CXHB2000125	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	Supplementary Application	2020-11-20	再鼎医药（上海）有限公司	Zai Lab (Shanghai) Co Ltd	In Review	2020-11-19	view
CYHB2008144	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	Supplementary Application	2020-10-27	再鼎医药（上海）有限公司,再鼎医药（苏州）有限公司	Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd	Certificate Issued	2021-10-25	view
CYHB2008100	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(2.4)	Supplementary Application	2020-10-26	再鼎医药（上海）有限公司	Zai Lab (Shanghai) Co Ltd;Zengding Pharmaceutical (Suzhou) Co Ltd	In Review	2020-10-23	view
CXHS2000009	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(2.4)	New Drug Application	2020-03-20	再鼎医药（苏州）有限公司	Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd	Certificate Issued	2020-09-16	view
CXHL1900377	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	New Drug Application	2019-11-29	再鼎医药（上海）有限公司	Zai Lab (Shanghai) Co Ltd	In Review	2019-11-28	view
CXHL1900376	甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	New Drug Application	2019-11-29	再鼎医药（上海）有限公司	Zai Lab (Shanghai) Co Ltd	In Review	2019-11-28	view
CXHS1800043	对甲苯磺酸尼拉帕利胶囊	niraparib tosylate	Capsule	Chemical Drugs(1)	New Drug Application	2018-12-17	再鼎医药（苏州）有限公司	Zengding Pharmaceutical (Suzhou) Co Ltd;Zai Lab (Shanghai) Co Ltd	Certificate Issued	2019-12-30	view