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 |
|---|
| 2015/09/28 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/05/17 |
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:ROPINIROLE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 2MG BASE 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 |
|---|
| 090869 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACTAVIS ELIZABETH |
| 201047 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
SANDOZ INC |
| 201576 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
Yes |
AB |
2012/06/06
|
DR REDDYS LABS LTD |
| 091395 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2012/08/27
|
CHARTWELL RX |
| 202786 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2013/04/22
|
ALEMBIC |
| 204413 |
001 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/05/11
|
PRINSTON INC |
活性成分:ROPINIROLE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 4MG BASE 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 |
|---|
| 090869 |
002 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACTAVIS ELIZABETH |
| 201047 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
SANDOZ INC |
| 201576 |
002 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
DR REDDYS LABS LTD |
| 091395 |
002 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/08/27
|
CHARTWELL RX |
| 202786 |
002 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2013/04/22
|
ALEMBIC |
| 204413 |
002 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2022/05/11
|
PRINSTON INC |
活性成分:ROPINIROLE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 6MG BASE 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 |
|---|
| 090869 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACTAVIS ELIZABETH |
| 201047 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
SANDOZ INC |
| 201576 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
DR REDDYS LABS LTD |
| 091395 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/08/27
|
CHARTWELL RX |
| 202786 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2013/04/22
|
ALEMBIC |
| 204413 |
003 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 6MG BASE |
Prescription |
No |
No |
AB |
2022/05/11
|
PRINSTON INC |
活性成分:ROPINIROLE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 8MG BASE 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 |
|---|
| 090869 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACTAVIS ELIZABETH |
| 201047 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
SANDOZ INC |
| 201576 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
DR REDDYS LABS LTD |
| 091395 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2012/08/27
|
CHARTWELL RX |
| 202786 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2013/04/22
|
ALEMBIC |
| 204413 |
004 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 8MG BASE |
Prescription |
No |
No |
AB |
2022/05/11
|
PRINSTON INC |
活性成分:ROPINIROLE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 12MG BASE 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 |
|---|
| 090869 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/05/17
|
ACTAVIS ELIZABETH |
| 201047 |
006 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
SANDOZ INC |
| 201576 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/06/06
|
DR REDDYS LABS LTD |
| 091395 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/08/27
|
CHARTWELL RX |
| 202786 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2013/04/22
|
ALEMBIC |
| 204413 |
005 |
ANDA |
ROPINIROLE HYDROCHLORIDE |
ROPINIROLE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 12MG BASE |
Prescription |
No |
No |
AB |
2022/05/11
|
PRINSTON INC |
