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
CXHS1800045	盐酸恩莎替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	New Drug Application	2019-01-02	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2020-11-24	view
CXHL1502061	X-396胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1.1)	New Drug Application	2015-11-30	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2016-08-12	view
JXHL1600114	X-396胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	Import Drug Application	2016-10-13	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2017-05-31	view
JXHL1600115	X-396胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	Import Drug Application	2016-10-13	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2017-05-31	view
CXHS1800046	盐酸恩莎替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	New Drug Application	2019-01-02	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2020-11-24	view
CXHL1502060	X-396胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1.1)	New Drug Application	2015-11-30	贝达药业股份有限公司	Betta Pharmaceuticals Co Ltd	Certificate Issued	2016-08-12	view
CYHB2101569	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	Supplementary Application	2021-07-13		Betta Pharmaceuticals Co Ltd			view
CXHL2200060	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(2.4)	New Drug Application	2022-01-28		Betta Pharmaceuticals Co Ltd			view
CXHS2101029	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(2.4)	New Drug Application	2021-07-13		Betta Pharmaceuticals Co Ltd			view
CYHB2101570	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(1)	Supplementary Application	2021-07-13		Betta Pharmaceuticals Co Ltd			view
CXHS2101028	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(2.4)	New Drug Application	2021-07-13		Betta Pharmaceuticals Co Ltd			view
CXHL2200061	盐酸恩沙替尼胶囊	Ensartinib Hydrochloride	Capsule	Chemical Drugs(2.4)	New Drug Application	2022-01-28		Betta Pharmaceuticals Co Ltd			view