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 |
|---|
| 2014/11/12 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2013/01/18 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2005/03/09 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 2004/03/15 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 2003/03/18 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 2003/03/18 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/02/19 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/06/29 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/05/01 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/05/01 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/25 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/11/29 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/10/06 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1998/12/09 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/09/18 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1997/11/12 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/09/09 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/23 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/09/24 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/07/31 |
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 HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 150MG BASE 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 |
|---|
| 065242 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
--
|
LANNETT |
| 050162 |
002 |
NDA |
CLEOCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 063029 |
001 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
1989/09/20
|
COSETTE |
| 063083 |
001 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
1991/07/31
|
WATSON LABS |
| 065061 |
001 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2001/02/02
|
SUN PHARM INDS LTD |
| 065194 |
001 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2004/03/22
|
EPIC PHARMA LLC |
| 065217 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2005/01/31
|
ZYDUS PHARMS USA |
| 065442 |
001 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2009/08/26
|
AUROBINDO PHARMA |
| 207402 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2018/11/05
|
MICRO LABS |
| 216957 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2023/03/10
|
GLENMARK PHARMS LTD |
活性成分:CLINDAMYCIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 300MG BASE 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 |
|---|
| 050162 |
003 |
NDA |
CLEOCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
Yes |
Yes |
AB |
1988/04/14
|
PFIZER |
| 065061 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2001/02/02
|
SUN PHARM INDS LTD |
| 063083 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Discontinued |
No |
No |
AB |
2003/03/18
|
WATSON LABS |
| 065194 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2004/03/22
|
EPIC PHARMA LLC |
| 065217 |
003 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2005/01/31
|
ZYDUS PHARMS USA |
| 063029 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Discontinued |
No |
No |
AB |
2005/08/05
|
COSETTE |
| 065442 |
002 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2009/08/26
|
AUROBINDO PHARMA |
| 207402 |
003 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2018/11/05
|
MICRO LABS |
| 216957 |
003 |
ANDA |
CLINDAMYCIN HYDROCHLORIDE |
CLINDAMYCIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 300MG BASE |
Prescription |
No |
No |
AB |
2023/03/10
|
GLENMARK PHARMS LTD |