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
CXHL1401393	奥美拉唑碳酸氢钠胶囊	omeprazole;Sodium bicarbonate	Capsule	Chemical Drugs(3.2)	New Drug Application	2014-12-26	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-04-21	view
CXHL1402169	安立生坦	ambrisentan	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2015-07-01	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-06-27	view
CXHL1402171	奥氮平氟西汀胶囊	fluoxetine hydrochloride;olanzapine	Capsule	Chemical Drugs(3.2)	New Drug Application	2015-07-09	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-08-12	view
CXHL1402172	奥氮平氟西汀胶囊	fluoxetine hydrochloride;olanzapine	Capsule	Chemical Drugs(3.2)	New Drug Application	2015-07-09	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-08-12	view
CXHL1402173	奥氮平氟西汀胶囊	fluoxetine hydrochloride;olanzapine	Capsule	Chemical Drugs(3.2)	New Drug Application	2015-07-09	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-08-12	view
CXHL1700219	SOCC-2胶囊	SOCC-2	Capsule	Chemical Drugs(2.2)	New Drug Application	2017-11-10	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2018-06-08	view
CXHL1700220	SOCC-2胶囊	SOCC-2	Capsule	Chemical Drugs(2.2)	New Drug Application	2017-11-10	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2018-06-08	view
CXHS1300069	奥美拉唑碳酸氢钠胶囊	omeprazole;Sodium bicarbonate	Capsule	Chemical Drugs(3.2)	New Drug Application	2013-07-12	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2015-04-22	view
CYHB1840074	口服补液盐散（Ⅲ）		Powder	Chemical Drugs	Supplementary Application	2018-09-19	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2019-10-18	view
CYHB1950685	奥美拉唑碳酸氢钠胶囊	omeprazole;Sodium bicarbonate	Capsule	Chemical Drugs	Supplementary Application	2019-09-26	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2021-02-18	view
CYHS1301585	口服补液盐散(Ⅲ)		Powder	Chemical Drugs(6)	Generic Drug	2014-01-29	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2018-01-04	view
CYHS1401309	甲磺酸倍他司汀	Betahistine mesylate	Active ingredient	Chemical Drugs(6)	Generic Drug	2014-12-31	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	In Review	2014-12-30	view
CYHS1401311	甲磺酸倍他司汀片	Betahistine mesylate	Tablet	Chemical Drugs(6)	Generic Drug	2014-12-31	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-18	view
CYHS1401312	甲磺酸倍他司汀片	Betahistine mesylate	Tablet	Chemical Drugs(6)	Generic Drug	2014-12-31	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-18	view
CYHS1401985	安立生坦片	ambrisentan	Tablet	Chemical Drugs(6)	Generic Drug	2015-09-23	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-06-27	view
CYHS1500478	盐酸莫西沙星	moxifloxacin hydrochloride	Active ingredient	Chemical Drugs(6)	Generic Drug	2016-01-15	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	In Review	2016-01-14	view
CYHS1500479	盐酸莫西沙星片	moxifloxacin hydrochloride	Tablet	Chemical Drugs(6)	Generic Drug	2016-01-05	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-27	view
CYHS1500618	乙酰半胱氨酸片	acetylcysteine	Tablet	Chemical Drugs(6)	Generic Drug	2016-01-05	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-24	view
CYHS1500619	乙酰半胱氨酸片	acetylcysteine	Tablet	Chemical Drugs(6)	Generic Drug	2016-01-07	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-27	view
CYHS1500621	瑞格列奈二甲双胍片(Ⅰ)	metformin hydrochloride;repaglinide	Tablet	Chemical Drugs(6)	Generic Drug	2016-01-11	厦门恩成制药有限公司	Xiamen Encheng Tragacanth Limited Company	Certificate Issued	2016-10-24	view