药品注册申请号:050733
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 ZITHROMAX AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes AP 1997/01/30 1997/01/30 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/04/24 SUPPL 47 Approval Labeling STANDARD
2017/03/29 SUPPL 46 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/02/10 SUPPL 43 Approval Labeling STANDARD
2016/05/24 SUPPL 40 Approval Labeling STANDARD
2014/06/24 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2014/06/06 SUPPL 31 Approval Labeling STANDARD
2013/02/19 SUPPL 35 Approval Labeling STANDARD
2012/06/06 SUPPL 34 Approval Labeling STANDARD
2011/11/16 SUPPL 33 Approval Labeling STANDARD
2011/01/28 SUPPL 30 Approval Labeling STANDARD
2010/08/11 SUPPL 29 Approval Labeling STANDARD
2009/03/06 SUPPL 23 Approval Labeling STANDARD
2007/10/25 SUPPL 18 Approval Labeling STANDARD
2004/01/15 SUPPL 13 Approval Labeling STANDARD
2004/01/15 SUPPL 12 Approval Labeling STANDARD
2003/06/12 SUPPL 7 Approval Labeling STANDARD
2002/10/16 SUPPL 6 Approval Labeling STANDARD
2002/07/22 SUPPL 10 Approval Labeling STANDARD
2002/03/13 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2001/02/28 SUPPL 5 Approval Labeling STANDARD
2000/11/11 SUPPL 4 Approval Labeling STANDARD
1999/11/22 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1999/10/19 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1999/07/20 SUPPL 1 Approval Labeling STANDARD
1997/01/30 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 6268489 2018/07/31 Y PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:AZITHROMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG BASE/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
050733 001 NDA ZITHROMAX AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription Yes Yes AP 1997/01/30 PFIZER
065179 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2005/12/13 FRESENIUS KABI USA
065506 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/03/24 MYLAN ASI
065511 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/06/26 HOSPIRA
065500 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/06/26 HOSPIRA
065501 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/11/09 GLAND PHARMA LTD
090923 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2013/04/02 SUN PHARM INDS LTD
203294 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2015/06/19 AUROBINDO PHARMA LTD
204732 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2017/01/26 MYLAN LABS LTD
203412 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2018/10/09 HAINAN POLY PHARM
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