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 |
|---|
| 2023/11/07 |
SUPPL-52（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/07 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/12/21 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/10/22 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/03/17 |
SUPPL-37（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2007/10/31 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/02/21 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/01/03 |
SUPPL-34（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/06/09 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/02/06 |
SUPPL-29（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/03/31 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/08/22 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/11/07 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1990/04/17 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/09 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/10 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/06/05 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/04/10 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/01/25 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/08/08 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/05/25 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/03/18 |
SUPPL-13（补充） |
Approval |
Efficacy |
|
|
|
| 1987/01/20 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/09/02 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/05/27 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/03/04 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/01/07 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/11/20 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/20 |
SUPPL-8（补充） |
Approval |
Efficacy |
|
|
|
| 1985/04/02 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/03/21 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1984/10/11 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/08/09 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/06 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/01/09 |
SUPPL-1（补充） |
Approval |
Efficacy |
|
|
|
| 1983/04/19 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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: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 |
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: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 |
