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 |
|---|
| 2024/04/24 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/15 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/13 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/13 |
SUPPL-24（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/12/30 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 2007/10/19 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 2007/07/02 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 2007/04/11 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2005/07/20 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 2002/02/20 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 2001/08/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/07/07 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/07/21 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/07/21 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/03/27 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1996/01/25 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/01/25 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/01/25 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/09/26 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1995/03/27 |
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:NORTRIPTYLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 10MG BASE 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 |
|---|
| 018013 |
001 |
NDA |
PAMELOR |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 073556 |
002 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
1992/03/30
|
DR REDDYS LABS SA |
| 074132 |
001 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
1995/03/27
|
TEVA |
| 075520 |
004 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2000/05/08
|
TARO |
活性成分:NORTRIPTYLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE 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 |
|---|
| 018013 |
002 |
NDA |
PAMELOR |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 073556 |
003 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
1992/03/30
|
DR REDDYS LABS SA |
| 074132 |
002 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
1995/03/27
|
TEVA |
| 075520 |
003 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2000/05/08
|
TARO |
活性成分:NORTRIPTYLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE 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 |
|---|
| 018013 |
004 |
NDA |
PAMELOR |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 073556 |
004 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1992/03/30
|
DR REDDYS LABS SA |
| 074132 |
003 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1995/03/27
|
TEVA |
| 075520 |
001 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2000/05/08
|
TARO |
活性成分:NORTRIPTYLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 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 |
|---|
| 018013 |
003 |
NDA |
PAMELOR |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 073556 |
001 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
1992/03/30
|
DR REDDYS LABS SA |
| 074132 |
004 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
1995/03/27
|
TEVA |
| 075520 |
002 |
ANDA |
NORTRIPTYLINE HYDROCHLORIDE |
NORTRIPTYLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2000/05/08
|
TARO |