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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | 065302 | 003 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 600MG BASE | No | No | 2008/02/11 | 2008/02/11 | CHARTWELL RX | Prescription |
AZITHROMYCIN | 065404 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | No | No | 2008/02/11 | 2008/02/11 | CHARTWELL RX | Prescription |
AZITHROMYCIN | 065405 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No | 2008/02/11 | 2008/02/11 | CHARTWELL RX | Prescription |
AZITHROMYCIN | 065419 | 001 | ANDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | No | 2008/06/24 | 2008/06/24 | TEVA PHARMS | Discontinued |
AZITHROMYCIN | 065419 | 002 | ANDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | No | No | 2008/06/24 | 2008/06/24 | TEVA PHARMS | Discontinued |
AZITHROMYCIN | 065506 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2009/03/24 | 2009/03/24 | NORVIUM BIOSCIENCE | Discontinued |
AZITHROMYCIN | 065500 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2009/06/26 | 2009/06/26 | HOSPIRA | Prescription |
AZITHROMYCIN | 065511 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2009/06/26 | 2009/06/26 | HOSPIRA | Prescription |
AZITHROMYCIN | 065501 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2009/11/09 | 2009/11/09 | GLAND PHARMA LTD | Prescription |
AZITHROMYCIN | 065507 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | No | No | 2011/07/13 | 2011/07/13 | APOTEX CORP | Discontinued |
AZITHROMYCIN | 065508 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 600MG BASE | No | No | 2011/07/13 | 2011/07/13 | APOTEX CORP | Discontinued |
AZITHROMYCIN | 065509 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No | 2011/07/13 | 2011/07/13 | APOTEX CORP | Discontinued |
AZITHROMYCIN | 090923 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2013/04/02 | 2013/04/02 | SUN PHARM INDS LTD | Discontinued |
AZITHROMYCIN | 202308 | 001 | ANDA | AZITHROMYCIN | SOLUTION; OPHTHALMIC | 1% | No | No | 2014/02/24 (TA) | -- | SANDOZ INC | None (Tentative Approval) |
AZITHROMYCIN | 065398 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | No | No | 2015/05/15 | 2015/05/15 | LUPIN LTD | Prescription |
AZITHROMYCIN | 065399 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No | 2015/05/15 | 2015/05/15 | LUPIN LTD | Prescription |
AZITHROMYCIN | 065400 | 001 | ANDA | AZITHROMYCIN | TABLET;ORAL | EQ 600MG BASE | No | No | 2015/05/15 | 2015/05/15 | LUPIN LTD | Prescription |
AZITHROMYCIN | 065488 | 001 | ANDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | No | 2015/05/15 | 2015/05/15 | CHARTWELL RX | Discontinued |
AZITHROMYCIN | 065488 | 002 | ANDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | No | No | 2015/05/15 | 2015/05/15 | CHARTWELL RX | Discontinued |
AZITHROMYCIN | 203294 | 001 | ANDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2015/06/19 | 2015/06/19 | EUGIA PHARMA | Prescription |