| 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 | 202163 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2013/08/05 | 2013/08/05 | CHARTWELL RX | Prescription |
| ZOLEDRONIC ACID | 202930 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2013/08/05 | 2013/08/05 | GLAND PHARMA LTD | Prescription |
| ZOLEDRONIC ACID | 202828 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2013/09/23 | 2013/09/23 | INFORLIFE | Prescription |
| ZOLEDRONIC ACID | 202548 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2014/05/22 | 2014/05/22 | EPIC PHARMA LLC | Prescription |
| ZOLEDRONIC ACID | 078475 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INJECTION | 4MG/5ML(0.8MG/ML) | No | No | 2014/05/29 (TA) | -- | CIPLA LTD | None (Tentative Approval) |
| ZOLEDRONIC ACID | 204051 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INJECTION | 4MG/100ML | No | No | 2014/07/03 (TA) | -- | SUN PHARMA GLOBAL | None (Tentative Approval) |
| ZOLEDRONIC ACID | 204138 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INJECTION | 5MG/100ML | No | No | 2014/07/22 (TA) | -- | SUN PHARMA GLOBAL | None (Tentative Approval) |
| ZOLEDRONIC ACID | 200918 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2014/08/21 | 2014/08/21 | EPIC PHARMA LLC | Prescription |
| ZOLEDRONIC ACID | 202923 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2014/09/04 | 2014/09/04 | USV | Prescription |
| ZOLEDRONIC ACID | 091493 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2014/11/24 | 2014/11/24 | SAGENT PHARMS INC | Prescription |
| ZOLEDRONIC ACID | 090621 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2015/03/19 | 2015/03/19 | HOSPIRA | Discontinued |
| ZOLEDRONIC ACID | 091516 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2015/04/23 | 2015/04/23 | FRESENIUS KABI USA | Prescription |
| ZOLEDRONIC ACID | 204367 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2015/12/24 | 2015/12/24 | APOTEX | Prescription |
| ZOLEDRONIC ACID | 204016 | 001 | NDA | ZOLEDRONIC ACID | SOLUTION;INTRAVENOUS | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | No | No | 2015/12/28 | 2015/12/28 | HOSPIRA | Prescription |
| ZOLEDRONIC ACID | 203344 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INJECTION | 4MG/5ML | No | No | 2016/02/09 (TA) | -- | PFIZER INC | None (Tentative Approval) |
| ZOLEDRONIC ACID | 204217 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2016/08/18 | 2016/08/18 | GLAND | Prescription |
| ZOLEDRONIC ACID | 207751 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2016/09/26 | 2016/09/26 | EUGIA PHARMA | Discontinued |
| ZOLEDRONIC ACID | 205279 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | No | No | 2016/11/28 | 2016/11/28 | ACCORD HLTHCARE | Prescription |
| ZOLEDRONIC ACID | 203841 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2017/02/14 | 2017/02/14 | MYLAN LABS LTD | Prescription |
| ZOLEDRONIC ACID | 205254 | 001 | ANDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | No | No | 2017/10/27 | 2017/10/27 | MYLAN LABS LTD | Prescription |