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 |
|---|
| 2002/05/15 |
SUPPL-98（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/03/25 |
SUPPL-97（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/26 |
SUPPL-96（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/05/05 |
SUPPL-95（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/03/12 |
SUPPL-94（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/03/12 |
SUPPL-93（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/03/12 |
SUPPL-92（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/03/12 |
SUPPL-91（补充） |
Approval |
Labeling |
|
|
|
| 1996/02/07 |
SUPPL-88（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/11/07 |
SUPPL-89（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/05/22 |
SUPPL-85（补充） |
Approval |
Labeling |
|
|
|
| 1986/03/21 |
SUPPL-82（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/07/05 |
SUPPL-77（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/03/01 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/04/12 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/04/12 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/01/25 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1976/02/03 |
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:MECLIZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG 治疗等效代码:AA
| 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 |
|---|
| 010721 |
006 |
NDA |
ANTIVERT |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
Yes |
No |
AA |
Approved Prior to Jan 1, 1982
|
CASPER PHARMA LLC |
| 084657 |
002 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Discontinued |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
ANI PHARMS |
| 087128 |
002 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
APNAR PHARMA LP |
| 084843 |
002 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
1989/05/22
|
SANDOZ |
| 040659 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2010/06/04
|
JUBILANT CADISTA |
| 201451 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
Yes |
AA |
2011/02/23
|
AMNEAL PHARMS |
| 200294 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2012/04/13
|
EPIC PHARMA LLC |
| 202640 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2012/09/17
|
AUROBINDO PHARMA USA |
| 205136 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2019/02/22
|
WILSHIRE PHARMS INC |
| 213957 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2020/06/23
|
ZYDUS LIFESCIENCES |
| 200432 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Discontinued |
No |
No |
AA |
2022/02/17
|
INVAGEN PHARMS |
| 203003 |
001 |
ANDA |
MECLIZINE HYDROCHLORIDE |
MECLIZINE HYDROCHLORIDE |
TABLET;ORAL |
12.5MG |
Prescription |
No |
No |
AA |
2022/08/11
|
CHARTWELL RX |