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
JYHB2400519	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Supplementary Application	2024-10-09		Renaissance Lakewood LLC;Janssen-Cilag International NV			view
JYHB2400118	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Supplementary Application	2024-03-09		Renaissance Lakewood LLC;Janssen-Cilag International NV			view
JYHB2500192	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Supplementary Application	2025-04-03		Renaissance Lakewood LLC;Janssen Cilag Manufacturing LLC;Janssen-Cilag International NV			view
JYHB2300611	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Supplementary Application	2023-10-26		Renaissance Lakewood LLC;Janssen-Cilag International NV			view
JYHB2500175	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Supplementary Application	2025-03-21		Renaissance Lakewood LLC;Janssen-Cilag International NV			view
JXHS2200017	盐酸艾司氯胺酮鼻喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs(5.1)	Import Drug Application	2022-01-27		Xian Janssen Pharmaceutical Ltd;Renaissance Lakewood LLC;Janssen-Cilag International NV			view
JXHL1500167	盐酸艾司氯胺酮鼻用喷雾剂	esketamine hydrochloride	Spray	Chemical Drugs	Import Drug Application	2015-07-17	Janssen Research & Development, LLC	Janssen Research & Development LLC	Certificate Issued	2016-06-12	view