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 |
|---|
| 2014/09/29 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2002/11/22 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2001/05/30 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/05/30 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/07/12 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1999/02/03 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1997/01/08 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/10/29 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1993/11/09 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1993/01/21 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1993/01/21 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1992/07/23 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1986/11/12 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1985/04/02 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1982/12/16 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1982/07/21 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1982/06/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 1982/03/29 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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:ACYCLOVIR 剂型/给药途径:OINTMENT;TOPICAL 规格:5% 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 |
|---|
| 018604 |
001 |
NDA |
ZOVIRAX |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
Yes |
Yes |
AB |
1982/03/29
|
BAUSCH |
| 202459 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2013/04/03
|
MYLAN PHARMS INC |
| 204605 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2014/06/18
|
AMNEAL PHARMS |
| 206633 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2016/05/11
|
FOUGERA PHARMS INC |
| 205469 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2016/12/21
|
TARO |
| 205510 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2017/07/31
|
GLENMARK SPECLT |
| 205591 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Discontinued |
No |
No |
AB |
2017/11/13
|
COSETTE |
| 209000 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2018/04/06
|
ALEMBIC |
| 209971 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2019/01/11
|
TORRENT |
| 211794 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2019/01/18
|
CIPLA |
| 205974 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2019/03/15
|
ZYDUS LIFESCIENCES |
| 210774 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2019/09/06
|
APOTEX |
| 201501 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2020/01/29
|
XIROMED |
| 212495 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2020/04/07
|
CHARTWELL RX |
| 212444 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
OINTMENT;TOPICAL |
5% |
Prescription |
No |
No |
AB |
2021/05/19
|
MACLEODS PHARMS LTD |
