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
CXHL1300295	咪达那新	imidafenacin	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2013-06-28	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-24	view
CXHL1300296	咪达那新片	imidafenacin	Tablet	Chemical Drugs(3.1)	New Drug Application	2013-06-28	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-24	view
CXHL1301209	布洛芬法莫替丁片	famotidine;ibuprofen	Tablet	Chemical Drugs(3.2)	New Drug Application	2014-01-14	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-07-14	view
CXHL1402108	枸橼酸托法替布	tofacitinib citrate	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-02-05	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-05-19	view
CXHL1402109	枸橼酸托法替布片	tofacitinib citrate	Tablet	Chemical Drugs(3.1)	New Drug Application	2015-02-05	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-05-19	view
CXHL1401241	枸橼酸西地那非注射液	sildenafil citrate	Injection	Chemical Drugs(3.3)	New Drug Application	2014-10-31	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2017-09-20	view
CXHL1300762	注射用福沙匹坦二甲葡胺	fosaprepitant dimeglumine	Lyophilized	Chemical Drugs(3.1)	New Drug Application	2013-11-21	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-15	view
CXHL1300761	注射用福沙匹坦二甲葡胺	fosaprepitant dimeglumine	Lyophilized	Chemical Drugs(3.1)	New Drug Application	2013-11-21	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-15	view
CXHL1300653	盐酸奥昔布宁凝胶	Oxybutynin Hydrochloride	Gel	Chemical Drugs(3.3)	New Drug Application	2013-08-07	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-30	view
CXHL1500794	盐酸氯卡色林	lorcaserin hydrochloride	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-07-22	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-08-12	view
CXHL1500795	盐酸氯卡色林片	lorcaserin hydrochloride	Tablet	Chemical Drugs(3.1)	New Drug Application	2015-07-22	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-08-12	view
CXHL1500015	盐酸考尼伐坦	conivaptan hydrochloride	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-02-10	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-05-19	view
CXHL1500018	盐酸考尼伐坦葡萄糖注射液	conivaptan hydrochloride	Injection	Chemical Drugs(3.1)	New Drug Application	2015-02-10	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-05-19	view
CXHR1600029	盐酸阿考替胺	acotiamide hydrochloride	Active ingredient	Chemical Drugs	State Standards	2016-04-13	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	In Review	2016-04-12	view
CXHL1400585	盐酸阿考替胺	acotiamide hydrochloride	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2014-06-16	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-02-03	view
CXHL1400586	盐酸阿考替胺片	acotiamide hydrochloride	Tablet	Chemical Drugs(3.1)	New Drug Application	2014-06-16	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2016-02-03	view
CXHR1600030	盐酸阿考替胺片	acotiamide hydrochloride	Tablet	Chemical Drugs	State Standards	2016-04-13	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2018-08-17	view
CXHL1300760	福沙匹坦二甲葡胺	fosaprepitant dimeglumine	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2013-11-21	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-12-24	view
CXHL1200719	罗氟司特	roflumilast	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2012-12-03	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-11-05	view
CXHL1200720	罗氟司特片	roflumilast	Tablet	Chemical Drugs(3.1)	New Drug Application	2012-12-03	南京艾德凯腾生物医药有限责任公司	Nanjing CoreTech Biomedical Co Ltd	Certificate Issued	2015-11-13	view