商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | 210174 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | No | No | 2017/10/27 | 2017/10/27 | AMNEAL | Prescription |
ZOLEDRONIC ACID | 209125 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2017/12/08 | 2017/12/08 | EUGIA PHARMA | Discontinued |
ZOLEDRONIC ACID | 207341 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2017/12/29 | 2017/12/29 | BPI LABS | Prescription |
ZOLEDRONIC | 205749 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | No | Yes | 2018/06/29 | 2018/06/29 | GLAND PHARMA LTD | Prescription |
ZOLEDRONIC ACID | 205749 | 002 | ANDA | ZOLEDRONIC ACID | INJECTABLE;IV (INFUSION) | EQ 4MG BASE/100ML | No | No | 2018/06/29 | -- | GLAND PHARMA LTD | None (Tentative Approval) |
ZOLEDRONIC ACID | 204344 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | No | No | 2018/11/19 | 2018/11/19 | DR REDDYS | Discontinued |
ZOLEDRONIC ACID | 208513 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2019/05/15 | 2019/05/15 | SHILPA | Discontinued |
ZOLEDRONIC ACID | 209578 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2019/08/08 | 2019/08/08 | GLAND PHARMA LTD | Prescription |
ZOLEDRONIC ACID | 208968 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2020/02/19 | 2020/02/19 | NOVAST LABS | Discontinued |
ZOLEDRONIC ACID | 213371 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2023/06/05 | 2023/06/05 | MEITHEAL | Prescription |