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 |
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) |
PRIORITY
|
|
|
1992/04/24 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/02/13 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/04/12 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/04/04 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1989/02/10 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/12/20 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
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) |
PRIORITY
|
|
|
1981/06/26 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/01/19 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/01/19 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/01/19 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/01/19 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/07/30 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
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) |
PRIORITY
|
|
|
1979/04/13 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/01/10 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1978/11/28 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
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 |
|
|
|
1963/02/15 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 | RLD | RS | TE 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% |
Prescription |
No |
No |
AT |
1982/04/27
|
TARO |
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 | RLD | RS | TE 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 | RLD | RS | TE 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% |
Prescription |
No |
No |
AT |
1982/04/27
|
TARO |
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 |