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 |
2020/08/20 |
SUPPL-229(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/01/19 |
SUPPL-221(补充) |
Approval |
Labeling |
|
|
|
2005/01/07 |
SUPPL-205(补充) |
Approval |
Labeling |
|
|
|
2004/07/07 |
SUPPL-200(补充) |
Approval |
Labeling |
|
|
|
2002/11/15 |
SUPPL-196(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/08/22 |
SUPPL-193(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/07/29 |
SUPPL-197(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/09/12 |
SUPPL-195(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/02/03 |
SUPPL-192(补充) |
Approval |
Labeling |
|
|
|
2000/02/03 |
SUPPL-190(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/01/28 |
SUPPL-191(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/04/30 |
SUPPL-188(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/04/30 |
SUPPL-187(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/04/30 |
SUPPL-186(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/12/09 |
SUPPL-185(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/05/13 |
SUPPL-184(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/01/13 |
SUPPL-183(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/05/30 |
SUPPL-182(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/04/24 |
SUPPL-181(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/10/06 |
SUPPL-177(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/08/17 |
SUPPL-180(补充) |
Approval |
Labeling |
|
|
|
1993/06/03 |
SUPPL-179(补充) |
Approval |
Labeling |
|
|
|
1993/03/12 |
SUPPL-178(补充) |
Approval |
Labeling |
|
|
|
1992/09/09 |
SUPPL-176(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/09/09 |
SUPPL-175(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/10 |
SUPPL-174(补充) |
Approval |
Bioequivalence |
|
|
|
1988/03/31 |
SUPPL-170(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/03/31 |
SUPPL-169(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/06/29 |
SUPPL-168(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/20 |
SUPPL-164(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/14 |
SUPPL-166(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/14 |
SUPPL-165(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/30 |
SUPPL-158(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/30 |
SUPPL-157(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/03/30 |
SUPPL-156(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1973/01/12 |
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:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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 |
083177 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
IVAX SUB TEVA PHARMS |
085182 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
HERITAGE PHARMS |
087059 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
OXFORD PHARMS |
040412 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2002/03/29
|
PRINSTON INC |
040702 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/03/16
|
LEADING |
040780 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/07/20
|
AUROBINDO PHARMA |
040807 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2007/07/20
|
IPCA LABS LTD |
040907 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/08/15
|
UNICHEM |
202556 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2012/09/24
|
ACCORD HLTHCARE |
203018 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/07/23
|
SCIEGEN PHARMS INC |
活性成分:HYDROCHLOROTHIAZIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
083177 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
IVAX SUB TEVA PHARMS |
085182 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
HERITAGE PHARMS |
087068 |
001 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
OXFORD PHARMS |
040412 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2002/03/29
|
PRINSTON INC |
040702 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/03/16
|
LEADING |
040780 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/07/20
|
AUROBINDO PHARMA |
040807 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/07/20
|
IPCA LABS LTD |
040907 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2008/08/15
|
UNICHEM |
202556 |
003 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2012/09/24
|
ACCORD HLTHCARE |
203018 |
002 |
ANDA |
HYDROCHLOROTHIAZIDE |
HYDROCHLOROTHIAZIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/07/23
|
SCIEGEN PHARMS INC |