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

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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
CXSS2400016	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(2.2)	New Drug Application	2024-02-05		Shandong E Hua Biology Medicine Co Ltd			view
CXSL2000082	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(1)	New Drug Application	2020-05-06	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2020-05-01	view
CXSL1700192	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(1)	New Drug Application	2018-03-12	昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	Certificate Issued	2018-11-19	view
CXSL1600127	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(1)	New Drug Application	2017-03-27	昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	Certificate Issued	2017-08-21	view
CXSL1500077	注射用重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(1)	New Drug Application	2015-09-23	山东阿华生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	Certificate Issued	2017-01-23	view
CXSS0500176	重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products	New Drug Application	2006-03-01	山东阿华生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	Certificate Issued	2007-10-10	view
CXSS0500175	重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products	New Drug Application	2006-03-01	山东阿华生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	Certificate Issued	2007-03-28	view
CSL01009	重组人组织型纤溶酶原激酶衍生物	Recombinant Human Tissue-type Plasminogen Activator Derivative	Lyophilized	Biological Products(2)	New Drug Application	2001-02-16	上海复旦张江生物医药股份有限公司	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd	Approval Completed-Pending Certificated	2002-06-10	view