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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2025/03/24 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:60MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 074910 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
1997/05/02
|
MYLAN |
| 212317 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
2021/03/22
|
GLENMARK PHARMS LTD |
| 215775 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
2022/05/05
|
DR REDDYS LABS SA |
| 217377 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
2023/03/01
|
TWI PHARMS |
| 219073 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
2025/03/24
|
UTOPIC PHARMS |
| 218032 |
001 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB1 |
2025/07/02
|
NOVAST LABS |
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:90MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 074910 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
1997/05/02
|
MYLAN |
| 212317 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
2021/03/22
|
GLENMARK PHARMS LTD |
| 215775 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
2022/05/05
|
DR REDDYS LABS SA |
| 217377 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
2023/03/01
|
TWI PHARMS |
| 219073 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
2025/03/24
|
UTOPIC PHARMS |
| 218032 |
002 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
90MG |
Prescription |
No |
No |
AB1 |
2025/07/02
|
NOVAST LABS |
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:120MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 074910 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
Yes |
AB1 |
1997/05/02
|
MYLAN |
| 212317 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB1 |
2021/03/22
|
GLENMARK PHARMS LTD |
| 215775 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB1 |
2022/05/05
|
DR REDDYS LABS SA |
| 217377 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB1 |
2023/03/01
|
TWI PHARMS |
| 219073 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB1 |
2025/03/24
|
UTOPIC PHARMS |
| 218032 |
003 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB1 |
2025/07/02
|
NOVAST LABS |