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 |
2022/06/29 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2017/02/23 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/01/10 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
2011/09/27 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2010/12/03 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
2009/07/16 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
2008/11/25 |
SUPPL-25(补充) |
Approval |
Labeling |
|
|
|
2008/05/29 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
2004/04/05 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
2001/11/06 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
2000/09/20 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/25 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/05 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/14 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/09/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/08/30 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1989/07/11 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/07/11 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/05/08 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1988/03/28 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/03/28 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/03/07 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1986/06/10 |
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:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:2MG 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 |
070278 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
Yes |
AB |
1986/06/10
|
MYLAN |
071173 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1987/01/02
|
INNOGENIX |
071130 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1987/02/17
|
AIPING PHARM INC |
211061 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
077580 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2023/01/17
|
ZYDUS PHARMS USA |
216918 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |
活性成分:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
071130 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1987/05/12
|
AIPING PHARM INC |
071173 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1988/01/07
|
INNOGENIX |
071210 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1988/03/11
|
CHARTWELL RX |
077580 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/11/29
|
ZYDUS PHARMS USA |
070278 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2009/07/16
|
MYLAN |
211061 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
216918 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |
活性成分:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:20MG 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 |
071173 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1988/01/07
|
INNOGENIX |
071211 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1988/03/11
|
CHARTWELL RX |
077580 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2007/11/29
|
ZYDUS PHARMS USA |
070278 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2009/07/16
|
MYLAN |
211061 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
216918 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |
活性成分:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:1MG 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 |
071207 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
--
|
SANDOZ |
070278 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1986/06/10
|
MYLAN |
071209 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1986/11/17
|
CHARTWELL RX |
071173 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1987/01/02
|
INNOGENIX |
211061 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
077580 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2023/01/17
|
ZYDUS PHARMS USA |
216918 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |
活性成分:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:5MG 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 |
070278 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
1986/06/10
|
MYLAN |
071209 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
1986/11/17
|
CHARTWELL RX |
071130 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
1987/02/17
|
AIPING PHARM INC |
071173 |
005 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
1988/01/07
|
INNOGENIX |
077580 |
003 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2007/11/29
|
ZYDUS PHARMS USA |
211061 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
216918 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
004 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |
活性成分:HALOPERIDOL 剂型/给药途径:TABLET;ORAL 规格:0.5MG 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 |
071206 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
--
|
SANDOZ |
070278 |
006 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1986/06/10
|
MYLAN |
071209 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1986/11/17
|
CHARTWELL RX |
071173 |
002 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1987/01/02
|
INNOGENIX |
211061 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2020/01/08
|
UPSHER SMITH LABS |
200854 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Discontinued |
No |
No |
AB |
2022/07/01
|
ACTAVIS GROUP |
216004 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2022/11/18
|
MSN |
077580 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2023/01/17
|
ZYDUS PHARMS USA |
216918 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2024/04/11
|
MANKIND PHARMA |
218789 |
001 |
ANDA |
HALOPERIDOL |
HALOPERIDOL |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2024/04/19
|
AUROBINDO PHARMA LTD |