| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMIKACIN SULFATE | 063167 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No | -- | 1995/12/14 | IGI LABS INC | Discontinued |
| AMIKACIN SULFATE | 063169 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | -- | 1995/12/14 | IGI LABS INC | Discontinued |
| AMIKACIN SULFATE | 063274 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No | 1992/05/18 | 1992/05/18 | HIKMA | Discontinued |
| AMIKACIN SULFATE | 063275 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1992/05/18 | 1992/05/18 | HIKMA | Discontinued |
| AMIKACIN SULFATE | 063350 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No | 1993/07/30 | 1993/07/30 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 063350 | 002 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1993/07/30 | 1993/07/30 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 064045 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No | 1993/09/28 | 1993/09/28 | MEITHEAL | Discontinued |
| AMIKACIN SULFATE | 064045 | 002 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1993/09/28 | 1993/09/28 | MEITHEAL | Prescription |
| AMIKACIN SULFATE | 063313 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | Yes | 1994/04/11 | 1994/04/11 | HIKMA | Prescription |
| AMIKACIN SULFATE | 063315 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1994/04/11 | 1994/04/11 | HIKMA | Prescription |
| AMIKACIN SULFATE | 063266 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1994/10/28 | 1994/10/31 | ABBOTT | Discontinued |
| AMIKACIN SULFATE | 063283 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 62.5MG BASE/ML | No | No | 1994/10/31 | 1994/10/31 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 063263 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | No | No | 1994/11/30 | 1994/11/30 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 063264 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1994/11/30 | 1994/11/30 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 063265 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1994/11/30 | 1994/11/30 | ABBOTT | Discontinued |
| AMIKACIN SULFATE | 064099 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1995/06/20 | 1995/06/20 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 064098 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 1995/06/26 | 1995/06/26 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 064146 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 500MG BASE/100ML | No | No | 1997/04/02 | 1997/04/02 | HOSPIRA | Discontinued |
| AMIKACIN SULFATE | 204040 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | Yes | 2013/12/12 | 2013/12/12 | AVET LIFESCIENCES | Prescription |
| AMIKACIN SULFATE | 205604 | 001 | ANDA | AMIKACIN SULFATE | INJECTABLE;INJECTION | EQ 250MG BASE/ML | No | No | 2015/12/09 | 2015/12/09 | FRESENIUS KABI USA | Prescription |