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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
IBANDRONATE SODIUM | 079194 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE; INJECTION | 1MG | No | No | 2009/04/03 (TA) | -- | TEVA PARENTERAL | None (Tentative Approval) |
IBANDRONATE SODIUM | 079002 | 001 | ANDA | IBANDRONATE SODIUM | TABLET; ORAL | 2.5MG | No | No | 2011/03/15 (TA) | -- | COBALT LABS INC | None (Tentative Approval) |
IBANDRONATE SODIUM | 078948 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2012/03/19 | 2012/03/19 | APOTEX INC | Prescription |
IBANDRONATE SODIUM | 078995 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2012/03/19 | 2012/03/19 | NORVIUM BIOSCIENCE | Discontinued |
IBANDRONATE SODIUM | 078998 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2012/03/19 | 2012/03/19 | ORBION PHARMS | Prescription |
IBANDRONATE SODIUM | 079003 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2012/03/20 | 2012/03/20 | WATSON LABS TEVA | Discontinued |
IBANDRONATE SODIUM | 078997 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | Yes | 2012/04/30 | 2012/04/30 | DR REDDYS LABS LTD | Prescription |
IBANDRONATE SODIUM | 078996 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2012/08/15 | 2012/08/15 | SUN PHARM INDUSTRIES | Discontinued |
IBANDRONATE SODIUM | 090853 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2014/02/14 | 2014/02/14 | SUN PHARM | Discontinued |
IBANDRONATE SODIUM | 202235 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2014/09/02 | 2014/09/02 | CHEMI SPA | Prescription |
IBANDRONATE SODIUM | 202671 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2014/09/02 | 2014/09/02 | MYLAN LABS LTD | Prescription |
IBANDRONATE SODIUM | 203987 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2014/09/02 | 2014/09/02 | AVET LIFESCIENCES | Discontinued |
IBANDRONATE SODIUM | 205332 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2015/08/19 | 2015/08/19 | EUGIA PHARMA | Prescription |
IBANDRONATE SODIUM | 204222 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | Yes | 2015/10/16 | 2015/10/16 | APOTEX | Prescription |
IBANDRONATE SODIUM | 206058 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2016/02/05 | 2016/02/05 | ACCORD HLTHCARE | Prescription |
IBANDRONATE SODIUM | 204502 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2016/03/11 | 2016/03/11 | AUROBINDO PHARMA | Prescription |
IBANDRONATE SODIUM | 206887 | 001 | ANDA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | No | No | 2017/10/31 | 2017/10/31 | MACLEODS PHARMS LTD | Prescription |
IBANDRONATE SODIUM | 204329 | 001 | ANDA | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No | 2021/06/16 | 2021/06/16 | NANG KUANG PHARM CO | Discontinued |