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 |
2024/06/18 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/14 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/14 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/14 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/14 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/14 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/10/21 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/09/27 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/03/13 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2001/12/06 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/11/30 |
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:METHADONE HYDROCHLORIDE 剂型/给药途径:CONCENTRATE;ORAL 规格:10MG/ML 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 |
017116 |
002 |
NDA |
METHADOSE |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
089897 |
001 |
ANDA |
METHADONE HYDROCHLORIDE INTENSOL |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
No |
No |
AA |
1988/09/06
|
HIKMA |
040088 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
No |
No |
AA |
1994/11/30
|
VISTAPHARM LLC |
040180 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
No |
No |
AA |
1998/04/30
|
HIKMA |
207368 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
No |
No |
AA |
2019/08/22
|
SPECGX LLC |
212093 |
001 |
ANDA |
METHADONE HYDROCHLORIDE |
METHADONE HYDROCHLORIDE |
CONCENTRATE;ORAL |
10MG/ML |
Prescription |
No |
No |
AA |
2020/11/02
|
LANNETT CO INC |