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 |
|---|
| 2017/09/11 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/08/18 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/08/18 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/08/18 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/08/18 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/08/18 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/04/05 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/10/01 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1998/01/12 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1996/04/30 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1996/02/02 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/09/23 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1992/10/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/07/06 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/03/22 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/10/16 |
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:CLINDAMYCIN PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 150MG BASE/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 |
|---|
| 050441 |
001 |
NDA |
CLEOCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 062800 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
1987/07/24
|
ALMAJECT |
| 062803 |
001 |
ANDA |
CLEOCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
1987/10/16
|
PFIZER |
| 062889 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
1988/04/25
|
HIKMA |
| 062943 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
1988/09/29
|
ALMAJECT |
| 065206 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
2004/09/24
|
HIKMA |
| 065346 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
2007/03/29
|
FRESENIUS KABI USA |
| 065347 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
2007/05/09
|
FRESENIUS KABI USA |
| 090108 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
2011/09/30
|
SAGENT PHARMS INC |
| 090109 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
INJECTABLE;INJECTION |
EQ 150MG BASE/ML |
Prescription |
No |
No |
AP |
2011/09/30
|
SAGENT PHARMS INC |