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
CYHB2008007	注射用磷酸左奥硝唑酯二钠	levornidazole disodium phosphate	Lyophilized	Chemical Drugs(原1.1)	Supplementary Application	2020-10-22	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	In Review	2020-10-21	view
CXHL1501372	福司氟康唑注射液	Fosfluconazole	Injection	Chemical Drugs(3.1)	New Drug Application	2015-10-15	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-12-08	view
CXHL1501383	福司氟康唑	Fosfluconazole	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-10-15	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-12-08	view
CXHL1501371	注射用福司氟康唑	Fosfluconazole	Lyophilized	Chemical Drugs(3.1)	New Drug Application	2015-10-15	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-12-08	view
CXHL1501389	泮托拉唑镁	pantoprazole magnesium	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-09-23	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-09-03	view
CXHL1501384	泮托拉唑镁肠溶片	pantoprazole magnesium	Tablet	Chemical Drugs(3.1)	New Drug Application	2015-09-23	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-09-03	view
CXHL1402198	左亚叶酸	levomefolate	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-04-15	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-23	view
CXHL1402199	注射用左亚叶酸钠	sodium levofolinate	Lyophilized	Chemical Drugs(3.1)	New Drug Application	2015-04-15	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-23	view
CXHL1501391	雷美替胺片	ramelteon	Tablet	Chemical Drugs(3.1)	New Drug Application	2015-08-31	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-23	view
CXHL1501390	雷美替胺	ramelteon	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-08-31	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-23	view
CXHL1402200	非诺贝酸胆碱		Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-05-07	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-04	view
CXHL1402201	非诺贝酸胆碱缓释片		Tablet, extended release	Chemical Drugs(3.1)	New Drug Application	2015-05-07	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-08-04	view
CXHL1401531	注射用HCP002		Lyophilized	Chemical Drugs(1.1)	New Drug Application	2014-12-17	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-03-01	view
CXHL1401530	HCP002	HCP-002	Other	Chemical Drugs(1.1)	New Drug Application	2014-12-17	陕西合成药业股份有限公司	Shaanxi Synthetic Pharmaceutical Co Ltd	Certificate Issued	2016-03-01	view