| Application Number | Application Type | Drug Name | Active Ingredients | Dosage Form/Route | Approval Date | Company |
|---|---|---|---|---|---|---|
| 218146 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | QILU | |
| 207356 | NDA | ARIKAYCE KIT | AMIKACIN SULFATE | SUSPENSION, LIPOSOMAL;INHALATION | 2018-09-28 | INSMED INC |
| 205605 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 2015-12-09 | FRESENIUS KABI USA |
| 205604 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 2015-12-09 | FRESENIUS KABI USA |
| 204040 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 2013-12-12 | AVET LIFESCIENCES |
| 203323 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 2016-05-12 | SAGENT PHARMS INC |
| 064146 | ANDA | AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1997-04-02 | HOSPIRA |
| 064099 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1995-06-20 | HOSPIRA |
| 064098 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1995-06-26 | HOSPIRA |
| 064045 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1993-09-28 | MEITHEAL |
| 063350 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1993-07-30 | HOSPIRA |
| 063315 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-04-11 | HIKMA |
| 063313 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-04-11 | HIKMA |
| 063283 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-10-31 | HOSPIRA |
| 063275 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1992-05-18 | HIKMA |
| 063274 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1992-05-18 | HIKMA |
| 063266 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-10-28 | ABBOTT |
| 063265 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-11-30 | ABBOTT |
| 063264 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-11-30 | HOSPIRA |
| 063263 | ANDA | AMIKACIN SULFATE | AMIKACIN SULFATE | INJECTABLE;INJECTION | 1994-11-30 | HOSPIRA |