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 |
2001/04/25 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/06/04 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/07/02 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/09/03 |
SUPPL-54(补充) |
Approval |
Labeling |
|
|
|
1991/05/31 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/19 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/29 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/01/19 |
SUPPL-53(补充) |
Approval |
Labeling |
|
|
|
1988/05/02 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/02 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/02 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/28 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/28 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/28 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/01/28 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/02/16 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1971/12/23 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:FOLIC ACID 剂型/给药途径:TABLET;ORAL 规格:1MG 治疗等效代码:AA
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 |
080680 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
040625 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
Yes |
AA |
2005/07/21
|
AMNEAL PHARM |
040796 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2009/01/12
|
LEADING |
090035 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2009/06/09
|
CHARTWELL MOLECULAR |
091145 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2013/07/12
|
QINGDAO BAHEAL PHARM |
202437 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2014/01/27
|
CADILA PHARMS LTD |
204418 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2015/07/28
|
NUVO PHARMS INC |
211064 |
001 |
ANDA |
FOLIC ACID |
FOLIC ACID |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AA |
2019/03/08
|
ATHEM |