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 |
|---|
| 1983/03/08 |
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 |
|---|
| 2025/06/25 |
SUPPL-23（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2024/10/31 |
SUPPL-24（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2023/12/15 |
SUPPL-22（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/06/02 |
SUPPL-21（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2020/05/05 |
SUPPL-20（补充） |
Approval |
REMS-Proposal |
|
|
|
| 1998/04/01 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/04/01 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/04/01 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/04/01 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/08/28 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/08/27 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/08/25 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/05/19 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1992/05/12 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1991/07/31 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/02/26 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1988/09/02 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/09/02 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/09/02 |
SUPPL-1（补充） |
Approval |
Bioequivalence |
|
|
|
| 1987/10/21 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
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:METHADONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 治疗等效代码:AA<<<
| 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 |
|---|
| 088109 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
1983/03/08
|
HIKMA |
| 040241 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AA |
1998/05/29
|
VISTAPHARM LLC |
| 040517 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
Yes |
AA |
2004/04/27
|
SPECGX LLC |
| 090635 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2009/11/25
|
THEPHARMANETWORK LLC |
| 090065 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2015/08/18
|
EPIC PHARMA LLC |
| 203502 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2015/08/31
|
AUROLIFE PHARMA LLC |
| 208305 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AA |
2018/03/30
|
SUN PHARM INDUSTRIES |
| 210484 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2018/08/02
|
ELITE LABS INC |
| 211228 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2019/01/03
|
ASCENT PHARMS INC |
| 204166 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AA |
2020/03/16
|
VISTAPHARM LLC |
>>>活性成分:METHADONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:5MG; 治疗等效代码:AA<<<
| 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 |
|---|
| 088109 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
1983/03/08
|
HIKMA |
| 040517 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
Yes |
AA |
2004/04/27
|
SPECGX LLC |
| 090065 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2015/08/18
|
EPIC PHARMA LLC |
| 203502 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2015/08/31
|
AUROLIFE PHARMA LLC |
| 208305 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AA |
2018/03/30
|
SUN PHARM INDUSTRIES |
| 210484 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2018/08/02
|
ELITE LABS INC |
| 211228 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2019/01/03
|
ASCENT PHARMS INC |
| 090635 |
002 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AA |
2020/09/22
|
THEPHARMANETWORK LLC |