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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1987/07/14 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2007/11/21 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2007/07/16 |
SUPPL-30（补充） |
Approval |
Labeling |
|
|
|
| 2007/06/29 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 2005/08/26 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 2005/05/05 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 2002/09/30 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2001/08/22 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2001/07/05 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2001/03/22 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2000/05/16 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/05/16 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1997/12/05 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/02/24 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/08/22 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1995/06/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/01/12 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/08/16 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1992/05/15 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1992/02/27 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:AMITRIPTYLINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:100MG; 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 |
|---|
| 089402 |
001 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
--
|
MUTUAL PHARM |
| 085968 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 089399 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1987/07/14
|
SUN PHARM INDS INC |
| 040218 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
1997/09/11
|
PH HEALTH |
| 202446 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2014/06/04
|
ACCORD HLTHCARE |
| 210086 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/10/06
|
ZYDUS PHARMS |
| 213999 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/02/19
|
MANKIND PHARMA |
| 214548 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/05/19
|
UNICHEM |
| 212654 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/09/29
|
AIPING PHARM INC |
| 216243 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2022/06/06
|
BRECKENRIDGE |
| 217411 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/05/19
|
RISING |
| 218389 |
005 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2025/06/23
|
UNIQUE PHARM |