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 |
2022/03/03 |
SUPPL-66(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/16 |
SUPPL-65(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/07/12 |
SUPPL-63(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/10/18 |
SUPPL-62(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/10/31 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/10/31 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/15 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/30 |
SUPPL-58(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/30 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/16 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/01/25 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/04/30 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/15 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/04/03 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/24 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/09/06 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/08/08 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/06 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/12/14 |
SUPPL-43(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/12/14 |
SUPPL-41(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/12/14 |
SUPPL-40(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/12/14 |
SUPPL-39(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/12/14 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/05/27 |
SUPPL-42(补充) |
Approval |
REMS |
N/A
|
|
|
2011/01/17 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/23 |
SUPPL-36(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2003/03/24 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/20 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/20 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/20 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/20 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/02/24 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/02/24 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/02/19 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/10/15 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/10 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/02/22 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/03/23 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1990/03/23 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1990/03/23 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1980/12/08 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/09/24 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/08/16 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1978/11/22 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1978/02/23 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/03/18 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1953/01/06 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
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 |
与本品治疗等效的药品
活性成分:PHENYTOIN 剂型/给药途径:SUSPENSION;ORAL 规格:125MG/5ML 治疗等效代码:AB
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 |
008762 |
001 |
NDA |
DILANTIN-125 |
PHENYTOIN |
SUSPENSION;ORAL |
125MG/5ML |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
VIATRIS |
040342 |
001 |
ANDA |
PHENYTOIN |
PHENYTOIN |
SUSPENSION;ORAL |
125MG/5ML |
Discontinued |
No |
No |
AB |
2001/01/31
|
VISTAPHARM |
040420 |
001 |
ANDA |
PHENYTOIN |
PHENYTOIN |
SUSPENSION;ORAL |
125MG/5ML |
Discontinued |
No |
No |
AB |
2002/04/19
|
PAI HOLDINGS PHARM |
040521 |
001 |
ANDA |
PHENYTOIN |
PHENYTOIN |
SUSPENSION;ORAL |
125MG/5ML |
Prescription |
No |
No |
AB |
2004/03/08
|
TARO |
040342 |
002 |
ANDA |
PHENYTOIN |
PHENYTOIN |
SUSPENSION;ORAL |
125MG/5ML |
Discontinued |
No |
No |
AB |
2005/08/18
|
VISTAPHARM |