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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2022/01/06 SUPPL-49(补充) Approval Manufacturing (CMC) N/A
2021/11/22 SUPPL-50(补充) Approval Labeling STANDARD
2019/04/24 SUPPL-47(补充) Approval Labeling STANDARD
2017/03/29 SUPPL-46(补充) 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(补充) Approval Labeling STANDARD
2016/05/24 SUPPL-40(补充) Approval Labeling STANDARD
2014/06/24 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2014/06/06 SUPPL-31(补充) Approval Labeling STANDARD
2013/02/19 SUPPL-35(补充) Approval Labeling STANDARD
2012/06/06 SUPPL-34(补充) Approval Labeling STANDARD
2011/11/16 SUPPL-33(补充) Approval Labeling STANDARD
2011/01/28 SUPPL-30(补充) Approval Labeling STANDARD
2010/08/11 SUPPL-29(补充) Approval Labeling STANDARD
2009/03/06 SUPPL-23(补充) Approval Labeling STANDARD
2007/10/25 SUPPL-18(补充) Approval Labeling STANDARD
2004/01/15 SUPPL-13(补充) Approval Labeling STANDARD
2004/01/15 SUPPL-12(补充) Approval Labeling STANDARD
2003/06/12 SUPPL-7(补充) Approval Labeling STANDARD
2002/10/16 SUPPL-6(补充) Approval Labeling STANDARD
2002/07/22 SUPPL-10(补充) Approval Labeling STANDARD
2002/03/13 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2001/02/28 SUPPL-5(补充) Approval Labeling STANDARD
2000/11/11 SUPPL-4(补充) Approval Labeling STANDARD
1999/11/22 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1999/10/19 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1999/07/20 SUPPL-1(补充) Approval Labeling STANDARD
1997/01/30 ORIG-1(原始申请) 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
065500 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/06/26 HOSPIRA
065511 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 Discontinued 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 EUGIA PHARMA
203412 001 ANDA AZITHROMYCIN AZITHROMYCIN INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2018/10/09 SLATE RUN PHARMA
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