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 |
|---|
| 2024/09/19 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/07/08 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/12/15 |
SUPPL-25（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/05 |
SUPPL-23（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/10/05 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/01/25 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/05/30 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| 2017/01/25 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/19 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2016/02/26 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/05/28 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/02/05 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/08/14 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/08/05 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/01/23 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/01/19 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/05/24 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2006/09/28 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity and Type 4 - New Combination |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:140MG;125MG;125MG 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 |
|---|
| 050786 |
001 |
NDA |
PYLERA |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
140MG;125MG;125MG |
Prescription |
Yes |
Yes |
AB |
2006/09/28
|
LABS JUVISE |
| 205770 |
001 |
ANDA |
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
140MG;125MG;125MG |
Prescription |
No |
No |
AB |
2023/03/06
|
ENDO OPERATIONS |
| 217511 |
001 |
ANDA |
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
CAPSULE;ORAL |
140MG;125MG;125MG |
Prescription |
No |
No |
AB |
2023/07/03
|
NOVAST LABS |
