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 |
2020/04/20 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/04/20 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/04/20 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/17 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/12/13 |
SUPPL-33(补充) |
Approval |
Labeling |
|
|
|
2008/01/30 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2001/06/07 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/07 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/07 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/07 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/10/31 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/07/07 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/03/15 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/09/16 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/09/16 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/09/16 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/09/16 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1992/03/02 |
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: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 |
Prescription |
No |
No |
AB |
2013/05/13
|
SUN PHARM INDS INC |