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![](/fda/pdf.jpg) | **本条是由Drugfuture回溯的历史信息** |
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 | RLD | RS | TE 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 |