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 |
|---|
| 2019/10/22 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/12/13 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/12/19 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 2010/07/06 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2008/02/27 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2003/11/19 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2002/12/20 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/05/08 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/04/16 |
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:FAMOTIDINE 剂型/给药途径:TABLET;ORAL 规格:20MG 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 |
|---|
| 075718 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
DR REDDYS LABS LTD |
| 075786 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CHARTWELL RX |
| 075805 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CARLSBAD |
| 075302 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
MANKIND PHARMA |
| 075511 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/04/16
|
IVAX SUB TEVA PHARMS |
| 075611 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2001/07/23
|
APOTEX |
| 077352 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Discontinued |
No |
No |
AB |
2005/07/27
|
PERRIGO R AND D |
| 078916 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2009/05/22
|
ALEMBIC PHARMS LTD |
| 206530 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2015/12/22
|
AUROBINDO PHARMA LTD |
| 215689 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/10/15
|
ASCENT PHARMS INC |
| 215767 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2021/11/04
|
ANNORA PHARMA |
| 215630 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/01/07
|
ALKEM LABS LTD |
| 216441 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2022/06/03
|
ZYDUS PHARMS |
| 217375 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/04/24
|
ALKEM LABS LTD |
| 217669 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/12/20
|
CONTRACT PHARMACAL |
| 218181 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2023/12/22
|
GRAVITI PHARMS |
活性成分:FAMOTIDINE 剂型/给药途径:TABLET;ORAL 规格:40MG 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 |
|---|
| 075718 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
DR REDDYS LABS LTD |
| 075786 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CHARTWELL RX |
| 075805 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
CARLSBAD |
| 075302 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
MANKIND PHARMA |
| 075511 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/04/16
|
IVAX SUB TEVA PHARMS |
| 075611 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2001/07/23
|
APOTEX |
| 077352 |
001 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Discontinued |
No |
No |
AB |
2005/07/27
|
PERRIGO R AND D |
| 078916 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2009/05/22
|
ALEMBIC PHARMS LTD |
| 206530 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
Yes |
AB |
2015/12/22
|
AUROBINDO PHARMA LTD |
| 215689 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2021/10/15
|
ASCENT PHARMS INC |
| 215767 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2021/11/04
|
ANNORA PHARMA |
| 215630 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2022/01/07
|
ALKEM LABS LTD |
| 216441 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2022/06/03
|
ZYDUS PHARMS |
| 217375 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/04/24
|
ALKEM LABS LTD |
| 217669 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/12/20
|
CONTRACT PHARMACAL |
| 218181 |
002 |
ANDA |
FAMOTIDINE |
FAMOTIDINE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2023/12/22
|
GRAVITI PHARMS |
