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 |
|---|
| 2015/08/26 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/07/02 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2012/12/21 |
SUPPL-6（补充） |
Tentative Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2011/01/21 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2009/08/13 |
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:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 45MG 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 |
|---|
| 090422 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Prescription |
No |
No |
AB |
2009/08/13
|
SANDOZ |
| 091424 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
CHARTWELL RX |
| 202261 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROBINDO PHARMA LTD |
| 091118 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Discontinued |
No |
No |
AB |
2014/09/25
|
SUN PHARM INDS LTD |
| 204394 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Prescription |
No |
No |
AB |
2015/12/30
|
SIDMAK LABS INDIA |
| 204453 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Prescription |
No |
No |
AB |
2016/09/28
|
ALKEM LABS LTD |
| 203553 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 45MG BASE |
Discontinued |
No |
No |
AB |
2017/11/16
|
ZYDUS PHARMS |
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 90MG 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 |
|---|
| 090422 |
002 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Prescription |
No |
No |
AB |
2009/08/13
|
SANDOZ |
| 091424 |
003 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
CHARTWELL RX |
| 202261 |
003 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROBINDO PHARMA LTD |
| 091118 |
005 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Discontinued |
No |
No |
AB |
2014/09/25
|
SUN PHARM INDS LTD |
| 204453 |
003 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Prescription |
No |
No |
AB |
2016/09/28
|
ALKEM LABS LTD |
| 203553 |
005 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 90MG BASE |
Discontinued |
No |
No |
AB |
2017/11/16
|
ZYDUS PHARMS |
活性成分:MINOCYCLINE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 135MG 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 |
|---|
| 090422 |
003 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Prescription |
No |
Yes |
AB |
2009/08/13
|
SANDOZ |
| 091424 |
004 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Prescription |
No |
No |
AB |
2011/11/30
|
CHARTWELL RX |
| 202261 |
005 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROBINDO PHARMA LTD |
| 091118 |
008 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Discontinued |
No |
No |
AB |
2014/09/25
|
SUN PHARM INDS LTD |
| 204394 |
007 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Prescription |
No |
No |
AB |
2015/12/30
|
SIDMAK LABS INDIA |
| 204453 |
005 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Prescription |
No |
No |
AB |
2016/09/28
|
ALKEM LABS LTD |
| 203553 |
008 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 135MG BASE |
Discontinued |
No |
No |
AB |
2017/11/16
|
ZYDUS PHARMS |