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 |
|---|
| 2007/05/04 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/05/04 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/05/04 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/05/04 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/05/04 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2007/05/04 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2006/07/31 |
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:PROMETHAZINE HYDROCHLORIDE 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 |
|---|
| 083426 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
| 084176 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040596 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2005/11/18
|
ZYDUS PHARMS USA |
| 040622 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2006/07/18
|
PRINSTON INC |
| 040712 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2006/07/31
|
KVK TECH |
| 040673 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/03/05
|
QUAGEN |
| 040863 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2008/12/30
|
SUN PHARM INDS INC |
| 091179 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2010/12/13
|
AMNEAL PHARMS NY |
| 209177 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2017/06/30
|
STRIDES PHARMA |
活性成分:PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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 |
|---|
| 040596 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2005/11/18
|
ZYDUS PHARMS USA |
| 040622 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2006/07/18
|
PRINSTON INC |
| 040712 |
002 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2007/05/04
|
KVK TECH |
| 040673 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2008/03/05
|
QUAGEN |
| 040863 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Discontinued |
No |
No |
AB |
2008/12/30
|
SUN PHARM INDS INC |
| 091179 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2010/12/13
|
AMNEAL PHARMS NY |
| 209177 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2017/06/30
|
STRIDES PHARMA |
活性成分:PROMETHAZINE HYDROCHLORIDE 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 |
|---|
| 040713 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
--
|
KVK TECH |
| 083711 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
WATSON LABS |
| 084176 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040596 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2005/11/18
|
ZYDUS PHARMS USA |
| 040622 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2006/07/18
|
PRINSTON INC |
| 040712 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2006/07/31
|
KVK TECH |
| 040673 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2008/03/05
|
QUAGEN |
| 040863 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2008/12/30
|
SUN PHARM INDS INC |
| 091179 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2010/12/13
|
AMNEAL PHARMS NY |
| 209177 |
003 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/06/30
|
STRIDES PHARMA |
