药品注册申请号：019452
申请类型：NDA (新药申请)
申请人：HILL DERMAC
申请人全名：HILL DERMACEUTICALS 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 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Yes Yes AT 1988/02/03 1988/02/03 Prescription
002 DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Yes Yes AT 2005/11/09 Prescription
003 DERMOTIC FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Yes Yes AT 2005/11/09 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
1988/02/03 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>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
2024/08/30 SUPPL-27（补充） Approval Labeling STANDARD
2020/01/29 SUPPL-40（补充） Approval Labeling-Container/Carton Labels STANDARD
2016/12/13 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2007/12/12 SUPPL-24（补充） Approval Efficacy-New Patient Population UNKNOWN
2007/12/03 SUPPL-25（补充） Approval Labeling-Package Insert N/A
2005/11/09 SUPPL-20（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2005/11/09 SUPPL-19（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
2005/11/09 SUPPL-16（补充） Approval Labeling STANDARD
2003/04/21 SUPPL-18（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/10/10 SUPPL-17（补充） Approval Efficacy-New Patient Population STANDARD
1999/08/18 SUPPL-15（补充） Approval Efficacy-New Indication STANDARD
1997/02/04 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/04/26 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1996/01/30 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1995/02/16 SUPPL-10（补充） Approval Efficacy-New Indication STANDARD
1995/02/16 SUPPL-9（补充） Approval Labeling STANDARD
1992/06/25 SUPPL-8（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/10/16 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1990/01/10 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1989/06/27 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1989/03/15 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1988/09/08 SUPPL-1（补充） Approval Manufacturing (CMC) 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
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
001 NPP 2010/12/12**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:FLUOCINOLONE ACETONIDE; 剂型/给药途径:OIL;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
019452 001 NDA DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription Yes Yes AT 1988/02/03 HILL DERMAC
019452 002 NDA DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription Yes Yes AT 2005/11/09 HILL DERMAC
201759 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2011/10/17 AMNEAL
201764 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2011/10/17 AMNEAL
202847 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2013/08/09 PADAGIS ISRAEL
202848 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2013/08/09 PADAGIS ISRAEL
203377 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/04/25 RISING
090982 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/04/25 RISING
202368 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/05/19 SUN PHARMA CANADA
209336 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/05/19 SUN PHARMA CANADA
210556 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2018/10/25 GLENMARK PHARMS LTD
210539 001 ANDA FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2018/10/26 GLENMARK PHARMS LTD
212760 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2021/04/02 QUAGEN
212761 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2021/04/02 QUAGEN
207345 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2023/07/31 NOVEL LABS INC
207347 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2023/08/07 NOVEL LABS INC
>>>活性成分:FLUOCINOLONE ACETONIDE; 剂型/给药途径:OIL;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
019452 001 NDA DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription Yes Yes AT 1988/02/03 HILL DERMAC
019452 002 NDA DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription Yes Yes AT 2005/11/09 HILL DERMAC
201759 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2011/10/17 AMNEAL
201764 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2011/10/17 AMNEAL
202847 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2013/08/09 PADAGIS ISRAEL
202848 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2013/08/09 PADAGIS ISRAEL
203377 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/04/25 RISING
090982 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/04/25 RISING
202368 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/05/19 SUN PHARMA CANADA
209336 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2016/05/19 SUN PHARMA CANADA
210556 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2018/10/25 GLENMARK PHARMS LTD
210539 001 ANDA FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Discontinued No No AT 2018/10/26 GLENMARK PHARMS LTD
212760 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2021/04/02 QUAGEN
212761 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2021/04/02 QUAGEN
207345 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2023/07/31 NOVEL LABS INC
207347 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL;TOPICAL 0.01% Prescription No No AT 2023/08/07 NOVEL LABS INC
>>>活性成分:FLUOCINOLONE ACETONIDE; 剂型/给药途径:OIL/DROPS;OTIC; 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
019452 003 NDA DERMOTIC FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription Yes Yes AT 2005/11/09 HILL DERMAC
091306 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Discontinued No No AT 2011/10/17 AMNEAL
203378 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription No No AT 2016/04/25 RISING
202849 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription No No AT 2017/07/17 PADAGIS ISRAEL
210736 001 ANDA FLAC FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription No No AT 2018/04/11 ANDA REPOSITORY
211815 001 ANDA FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Discontinued No No AT 2018/12/14 GLENMARK PHARMS LTD
213264 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription No No AT 2021/02/05 TP ANDA HOLDINGS
212762 001 ANDA FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE OIL/DROPS;OTIC 0.01% Prescription No No AT 2021/04/02 QUAGEN
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
©2006-2025 DrugFuture->U.S. FDA Drugs Database