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 |
|---|
| 1980/04/29 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
>>>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 |
|---|
| 2014/05/09 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2007/01/10 |
SUPPL-13（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
N/A
|
|
|
| 1995/03/22 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/12/23 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1993/09/16 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1990/01/22 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1988/08/02 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1987/09/24 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1987/07/14 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/28 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1984/06/14 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1984/01/31 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1983/07/01 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1980/08/14 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
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:OXYTOCIN; 剂型/给药途径:INJECTABLE;INJECTION; 规格:10USP UNITS/ML (10USP UNITS/ML); 治疗等效代码:AP<<<
| 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 |
|---|
| 018243 |
001 |
NDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
10USP UNITS/ML (10USP UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 018248 |
001 |
NDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
10USP UNITS/ML (10USP UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 018261 |
001 |
NDA |
PITOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
10USP UNITS/ML (10USP UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
PH HEALTH |
| 200219 |
001 |
ANDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
10USP UNITS/ML (10USP UNITS/ML) |
Prescription |
No |
No |
AP |
2013/02/13
|
HIKMA FARMACEUTICA |
| 091676 |
001 |
ANDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
10USP UNITS/ML (10USP UNITS/ML) |
Prescription |
No |
No |
AP |
2018/07/13
|
SAGENT PHARMS INC |
>>>活性成分:OXYTOCIN; 剂型/给药途径:INJECTABLE;INJECTION; 规格:100USP UNITS/10ML (10USP UNITS/ML); 治疗等效代码:AP<<<
| 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 |
|---|
| 018248 |
002 |
NDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
100USP UNITS/10ML (10USP UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 018243 |
002 |
NDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
100USP UNITS/10ML (10USP UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
2007/01/10
|
HIKMA |
| 018261 |
002 |
NDA |
PITOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
100USP UNITS/10ML (10USP UNITS/ML) |
Prescription |
Yes |
No |
AP |
2007/07/27
|
PH HEALTH |
| 091676 |
002 |
ANDA |
OXYTOCIN |
OXYTOCIN |
INJECTABLE;INJECTION |
100USP UNITS/10ML (10USP UNITS/ML) |
Prescription |
No |
No |
AP |
2018/07/13
|
SAGENT PHARMS INC |