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 |
|---|
| 1992/03/02 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2020/04/20 |
SUPPL-39（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2020/04/20 |
SUPPL-37（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2020/04/20 |
SUPPL-36（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/06/17 |
SUPPL-35（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2010/12/13 |
SUPPL-33（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2008/01/30 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 2001/06/07 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/12/07 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/12/07 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/12/07 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/10/31 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/07/07 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/03/15 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/09/16 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1999/09/16 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1999/09/16 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1999/09/16 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1997/12/10 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/18 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/04/29 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1995/02/16 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/09/06 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/03/31 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1993/11/02 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/10/06 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1993/06/11 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/06/11 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/17 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:CAPSULE;ORAL; 规格:EQ 50MG 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 |
|---|
| 050649 |
001 |
NDA |
MINOCIN |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
Yes |
No |
AB |
1990/05/31
|
BAUSCH |
| 063067 |
003 |
ANDA |
DYNACIN |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Discontinued |
No |
No |
AB |
1990/08/14
|
ALVOGEN |
| 063181 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1991/12/30
|
WATSON LABS TEVA |
| 063011 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1992/03/02
|
ZYDUS |
| 065005 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1999/03/23
|
IMPAX LABS |
| 065062 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2000/11/30
|
TORRENT |
| 065470 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2008/03/11
|
AUROBINDO PHARMA |
| 090867 |
001 |
ANDA |
MINOCYCLINE HYDROCHLORIDE |
MINOCYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Discontinued |
No |
No |
AB |
2013/05/13
|
SUN PHARM INDS INC |