药品注册申请号：011525
申请类型：NDA (新药申请)
申请人：RENEW PHARMS
申请人全名：RENEW PHARMACEUTICALS LTD
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 IC-GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 25MG/VIAL Yes No AP 1959/02/09 Approved Prior to Jan 1, 1982 Prescription
002 IC-GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
003 IC-GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
004 IC-GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1959/02/09 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/12/05 SUPPL-39（补充） Approval Efficacy-New Indication STANDARD
2022/08/08 SUPPL-31（补充） Tentative Approval Manufacturing (CMC)-Manufacturing Process N/A
2022/03/17 SUPPL-36（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2015/10/05 SUPPL-27（补充） Approval Labeling-Package Insert STANDARD
2006/09/22 SUPPL-17（补充） Approval Labeling STANDARD
1998/03/02 SUPPL-15（补充） Approval Manufacturing (CMC)-Control PRIORITY
1997/10/21 SUPPL-14（补充） Approval Manufacturing (CMC) PRIORITY
1995/03/30 SUPPL-13（补充） Approval Manufacturing (CMC)-Control PRIORITY
1995/03/30 SUPPL-12（补充） Approval Manufacturing (CMC)-Control PRIORITY
1991/06/05 SUPPL-11（补充） Approval Labeling
1989/08/02 SUPPL-9（补充） Approval Manufacturing (CMC) PRIORITY
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
无
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
无
与本品治疗等效的药品
>>>活性成分:INDOCYANINE GREEN; 剂型/给药途径:INJECTABLE;INJECTION; 规格:25MG/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
011525 001 NDA IC-GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 25MG/VIAL Prescription Yes No AP Approved Prior to Jan 1, 1982 RENEW PHARMS
040811 001 ANDA INDOCYANINE GREEN INDOCYANINE GREEN INJECTABLE;INJECTION 25MG/VIAL Prescription No Yes AP 2007/11/21 RENEW PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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