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 |
|---|
| 2019/09/05 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/10/14 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/14 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/12/01 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/07/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/07/14 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/09/30 |
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:CLINDAMYCIN PHOSPHATE 剂型/给药途径:SOLUTION;TOPICAL 规格:EQ 1% BASE 治疗等效代码:AT
| 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 |
|---|
| 063329 |
001 |
ANDA |
CLINDA-DERM |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
1992/09/30
|
PADAGIS US |
| 064050 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
Yes |
AT |
1995/11/30
|
PADAGIS US |
| 064159 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
1997/06/05
|
FOUGERA PHARMS INC |
| 065184 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
2004/03/31
|
TARO PHARM INDS |
| 206945 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Discontinued |
No |
No |
AT |
2016/12/30
|
PAI HOLDINGS PHARM |
| 209846 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
2018/02/08
|
CHARTWELL RX |
| 208767 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
2018/07/16
|
ZYDUS LIFESCIENCES |
| 209914 |
001 |
ANDA |
CLINDAMYCIN PHOSPHATE |
CLINDAMYCIN PHOSPHATE |
SOLUTION;TOPICAL |
EQ 1% BASE |
Prescription |
No |
No |
AT |
2019/01/28
|
ENCUBE ETHICALS |