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 |
|---|
| 2011/03/25 |
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:PROPRANOLOL HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:60MG 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 |
|---|
| 018553 |
004 |
NDA |
INDERAL LA |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
Yes |
No |
AB |
1987/03/18
|
ANI PHARMS |
| 078065 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2007/01/26
|
NORTEC DEV ASSOC |
| 078494 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2007/08/10
|
ACTAVIS ELIZABETH |
| 090321 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2011/03/25
|
ZYDUS PHARMS USA INC |
| 078703 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2011/07/15
|
ADARE PHARMS INC |
| 212026 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB |
2020/01/06
|
AMTA |
| 204349 |
001 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Discontinued |
No |
No |
AB |
2024/01/12
|
LUPIN LTD |
活性成分:PROPRANOLOL HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:80MG 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 |
|---|
| 018553 |
002 |
NDA |
INDERAL LA |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
Yes |
No |
AB |
1983/04/19
|
ANI PHARMS |
| 078065 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
No |
No |
AB |
2007/01/26
|
NORTEC DEV ASSOC |
| 078494 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
No |
No |
AB |
2007/08/10
|
ACTAVIS ELIZABETH |
| 090321 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
No |
No |
AB |
2011/03/25
|
ZYDUS PHARMS USA INC |
| 078703 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
No |
No |
AB |
2011/07/15
|
ADARE PHARMS INC |
| 212026 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Prescription |
No |
No |
AB |
2020/01/06
|
AMTA |
| 204349 |
002 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
80MG |
Discontinued |
No |
No |
AB |
2024/01/12
|
LUPIN LTD |
活性成分:PROPRANOLOL HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:120MG 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 |
|---|
| 018553 |
003 |
NDA |
INDERAL LA |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
Yes |
No |
AB |
1983/04/19
|
ANI PHARMS |
| 078065 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2007/01/26
|
NORTEC DEV ASSOC |
| 078494 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2007/08/10
|
ACTAVIS ELIZABETH |
| 090321 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2011/03/25
|
ZYDUS PHARMS USA INC |
| 078703 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2011/07/15
|
ADARE PHARMS INC |
| 212026 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2020/01/06
|
AMTA |
| 204349 |
003 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
Discontinued |
No |
No |
AB |
2024/01/12
|
LUPIN LTD |
活性成分:PROPRANOLOL HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:160MG 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 |
|---|
| 018553 |
001 |
NDA |
INDERAL LA |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
Yes |
Yes |
AB |
1983/04/19
|
ANI PHARMS |
| 078065 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
No |
No |
AB |
2007/01/26
|
NORTEC DEV ASSOC |
| 078494 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
No |
No |
AB |
2007/08/10
|
ACTAVIS ELIZABETH |
| 090321 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
No |
No |
AB |
2011/03/25
|
ZYDUS PHARMS USA INC |
| 078703 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
No |
No |
AB |
2011/07/15
|
ADARE PHARMS INC |
| 212026 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Prescription |
No |
No |
AB |
2020/01/06
|
AMTA |
| 204349 |
004 |
ANDA |
PROPRANOLOL HYDROCHLORIDE |
PROPRANOLOL HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
160MG |
Discontinued |
No |
No |
AB |
2024/01/12
|
LUPIN LTD |