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 |
|---|
| 2022/10/06 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2022/04/26 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2022/03/29 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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:NIFEDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:30MG 治疗等效代码:AB2
| 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 |
|---|
| 019684 |
001 |
NDA |
PROCARDIA XL |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
Yes |
No |
AB2 |
1989/09/06
|
PFIZER |
| 075289 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2001/02/06
|
VALEANT PHARMS NORTH |
| 077127 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2005/11/21
|
OSMOTICA PHARM US |
| 203126 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2014/04/03
|
TWI PHARMS |
| 210012 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2017/12/19
|
ZYDUS PHARMS |
| 210614 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2019/03/12
|
NOVAST LABS |
| 210838 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2019/04/16
|
SPIL |
| 216067 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2022/03/29
|
ALKEM LABS LTD |
| 216896 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB2 |
2022/11/18
|
ALEMBIC |
| 216019 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
30MG |
Discontinued |
No |
No |
AB2 |
2022/11/18
|
SWISS PHARM |
活性成分:NIFEDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:60MG 治疗等效代码:AB2
| 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 |
|---|
| 019684 |
002 |
NDA |
PROCARDIA XL |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
Yes |
No |
AB2 |
1989/09/06
|
PFIZER |
| 075289 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2000/09/27
|
VALEANT PHARMS NORTH |
| 077127 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2005/11/21
|
OSMOTICA PHARM US |
| 203126 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2014/04/03
|
TWI PHARMS |
| 210012 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2017/12/19
|
ZYDUS PHARMS |
| 210614 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2019/03/12
|
NOVAST LABS |
| 210838 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2019/04/16
|
SPIL |
| 216067 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2022/03/29
|
ALKEM LABS LTD |
| 216896 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2022/11/18
|
ALEMBIC |
| 216019 |
002 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
60MG |
Discontinued |
No |
No |
AB2 |
2022/11/18
|
SWISS PHARM |
活性成分:NIFEDIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:90MG 治疗等效代码:AB2
| 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 |
|---|
| 019684 |
003 |
NDA |
PROCARDIA XL |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
Yes |
Yes |
AB2 |
1989/09/06
|
PFIZER |
| 077127 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2007/10/03
|
OSMOTICA PHARM US |
| 203126 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2014/04/03
|
TWI PHARMS |
| 210012 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2017/12/19
|
ZYDUS PHARMS |
| 210614 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2019/03/12
|
NOVAST LABS |
| 210838 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2019/04/16
|
SPIL |
| 212016 |
001 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2020/11/18
|
ELITE PHARM SOLUTION |
| 216067 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2022/03/29
|
ALKEM LABS LTD |
| 216896 |
003 |
ANDA |
NIFEDIPINE |
NIFEDIPINE |
TABLET, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB2 |
2022/11/18
|
ALEMBIC |