药品注册申请号：012787
申请类型：NDA (新药申请)
申请人：MEDIMETRIKS PHARMS
申请人全名：MEDIMETRIKS PHARMACEUTICALS 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
002 SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Yes Yes AT 1963/02/15 Approved Prior to Jan 1, 1982 Prescription
004 SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.01% Yes Yes AT Approved Prior to Jan 1, 1982 Prescription
005 SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Yes Yes AT Approved Prior to Jan 1, 1982 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
>>>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
1963/02/15 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
2013/03/28 SUPPL-71（补充） Approval Manufacturing (CMC) PRIORITY
2000/09/26 SUPPL-66（补充） Approval Manufacturing (CMC) PRIORITY
1996/07/22 SUPPL-65（补充） Approval Manufacturing (CMC) PRIORITY
1995/03/06 SUPPL-61（补充） Approval Labeling
1995/03/06 SUPPL-60（补充） Approval Labeling
1995/03/01 SUPPL-64（补充） Approval Labeling STANDARD
1992/11/13 SUPPL-63（补充） Approval Manufacturing (CMC)-Control PRIORITY
1992/04/24 SUPPL-62（补充） Approval Manufacturing (CMC)-Control PRIORITY
1990/02/13 SUPPL-59（补充） Approval Manufacturing (CMC)-Control PRIORITY
1989/04/12 SUPPL-56（补充） Approval Manufacturing (CMC)-Control PRIORITY
1989/04/04 SUPPL-58（补充） Approval Manufacturing (CMC)-Control PRIORITY
1989/02/10 SUPPL-57（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/12/20 SUPPL-55（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1984/08/29 SUPPL-54（补充） Approval Manufacturing (CMC) PRIORITY
1983/09/07 SUPPL-53（补充） Approval Manufacturing (CMC) PRIORITY
1983/04/08 SUPPL-52（补充） Approval Labeling
1982/11/19 SUPPL-50（补充） Approval Manufacturing (CMC) PRIORITY
1981/11/20 SUPPL-49（补充） Approval Manufacturing (CMC) PRIORITY
1981/11/12 SUPPL-48（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/06/26 SUPPL-43（补充） Approval Manufacturing (CMC) PRIORITY
1981/01/19 SUPPL-47（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1981/01/19 SUPPL-46（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1981/01/19 SUPPL-45（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1981/01/19 SUPPL-44（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1980/07/30 SUPPL-42（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1980/02/19 SUPPL-40（补充） Approval Labeling
1980/02/19 SUPPL-39（补充） Approval Labeling
1979/10/23 SUPPL-38（补充） Approval Manufacturing (CMC) PRIORITY
1979/08/13 SUPPL-37（补充） Approval Manufacturing (CMC) PRIORITY
1979/07/25 SUPPL-36（补充） Approval Manufacturing (CMC)-Control PRIORITY
1979/04/13 SUPPL-34（补充） Approval Manufacturing (CMC)-Control PRIORITY
1979/01/10 SUPPL-31（补充） Approval Labeling
1978/11/28 SUPPL-33（补充） Approval Manufacturing (CMC)-Control PRIORITY
1978/09/12 SUPPL-32（补充） Approval Labeling
1977/06/04 SUPPL-30（补充） Approval Manufacturing (CMC) PRIORITY
1977/01/04 SUPPL-29（补充） Approval Labeling
1976/07/08 SUPPL-28（补充） Approval Labeling
1975/12/12 SUPPL-27（补充） Approval Labeling
1975/06/26 SUPPL-26（补充） Approval Labeling
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:FLUOCINOLONE ACETONIDE; 剂型/给药途径:CREAM;TOPICAL; 规格:0.025%; 治疗等效代码:AT<<<
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
012787 002 NDA SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MEDIMETRIKS PHARMS
012787 005 NDA SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MEDIMETRIKS PHARMS
087104 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Discontinued No No AT 1982/04/27 SUN PHARMA CANADA
088169 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 1982/12/16 FOUGERA PHARMS INC
210747 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2018/11/05 COSETTE
>>>活性成分:FLUOCINOLONE ACETONIDE; 剂型/给药途径:CREAM;TOPICAL; 规格:0.01%; 治疗等效代码:AT<<<
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
012787 004 NDA SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.01% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MEDIMETRIKS PHARMS
088170 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.01% Prescription No No AT 1982/12/16 FOUGERA PHARMS INC
089526 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.01% Prescription No No AT 1988/07/26 COSETTE
>>>活性成分:FLUOCINOLONE ACETONIDE; 剂型/给药途径:CREAM;TOPICAL; 规格:0.025%; 治疗等效代码:AT<<<
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
012787 002 NDA SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MEDIMETRIKS PHARMS
012787 005 NDA SYNALAR FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MEDIMETRIKS PHARMS
087104 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Discontinued No No AT 1982/04/27 SUN PHARMA CANADA
088169 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 1982/12/16 FOUGERA PHARMS INC
210747 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE CREAM;TOPICAL 0.025% Prescription No No AT 2018/11/05 COSETTE
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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