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 |
|---|
| 2021/07/06 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:39MG/0.25ML (39MG/0.25ML) 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 |
|---|
| 022264 |
001 |
NDA |
INVEGA SUSTENNA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
39MG/0.25ML (39MG/0.25ML) |
Prescription |
Yes |
No |
AB |
2009/07/31
|
JANSSEN PHARMS |
| 211149 |
001 |
ANDA |
PALIPERIDONE PALMITATE |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
39MG/0.25ML (39MG/0.25ML) |
Prescription |
No |
No |
AB |
2021/07/06
|
TEVA PHARMS USA |
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:78MG/0.5ML (78MG/0.5ML) 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 |
|---|
| 022264 |
002 |
NDA |
INVEGA SUSTENNA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
78MG/0.5ML (78MG/0.5ML) |
Prescription |
Yes |
No |
AB |
2009/07/31
|
JANSSEN PHARMS |
| 211149 |
002 |
ANDA |
PALIPERIDONE PALMITATE |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
78MG/0.5ML (78MG/0.5ML) |
Prescription |
No |
No |
AB |
2021/07/06
|
TEVA PHARMS USA |
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:117MG/0.75ML (117MG/0.75ML) 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 |
|---|
| 022264 |
003 |
NDA |
INVEGA SUSTENNA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
117MG/0.75ML (117MG/0.75ML) |
Prescription |
Yes |
No |
AB |
2009/07/31
|
JANSSEN PHARMS |
| 211149 |
003 |
ANDA |
PALIPERIDONE PALMITATE |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
117MG/0.75ML (117MG/0.75ML) |
Prescription |
No |
No |
AB |
2021/07/06
|
TEVA PHARMS USA |
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:156MG/ML (156MG/ML) 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 |
|---|
| 022264 |
004 |
NDA |
INVEGA SUSTENNA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
156MG/ML (156MG/ML) |
Prescription |
Yes |
Yes |
AB |
2009/07/31
|
JANSSEN PHARMS |
| 211149 |
004 |
ANDA |
PALIPERIDONE PALMITATE |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
156MG/ML (156MG/ML) |
Prescription |
No |
No |
AB |
2021/07/06
|
TEVA PHARMS USA |
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:234MG/1.5ML (156MG/ML) 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 |
|---|
| 022264 |
005 |
NDA |
INVEGA SUSTENNA |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
234MG/1.5ML (156MG/ML) |
Prescription |
Yes |
No |
AB |
2009/07/31
|
JANSSEN PHARMS |
| 211149 |
005 |
ANDA |
PALIPERIDONE PALMITATE |
PALIPERIDONE PALMITATE |
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
234MG/1.5ML (156MG/ML) |
Prescription |
No |
No |
AB |
2021/07/06
|
TEVA PHARMS USA |
