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 |
2007/11/21 |
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) |
|
|
|
2001/08/22 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
2001/07/05 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/03/22 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/05/16 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/05/16 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1987/07/14 |
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:AMITRIPTYLINE 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 |
089400 |
001 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
--
|
MUTUAL PHARM |
085968 |
001 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
089399 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1987/07/14
|
SUN PHARM INDS INC |
040218 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
1997/09/11
|
ENDO OPERATIONS |
202446 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/06/04
|
ACCORD HLTHCARE |
210086 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/10/06
|
ZYDUS PHARMS |
213999 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/02/19
|
MANKIND PHARMA |
214548 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/05/19
|
UNICHEM |
212654 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/09/29
|
AIPING PHARM INC |
216243 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/06/06
|
BRECKENRIDGE |
215376 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/05/01
|
RUBICON |
217411 |
003 |
ANDA |
AMITRIPTYLINE HYDROCHLORIDE |
AMITRIPTYLINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/05/19
|
RISING |