Drug application
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (AMIKACIN SULFATE)
Drugs@FDA ANDA 064146 · HOSPIRA
Key facts
| Drug name | AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | AMIKACIN SULFATE |
| Application type | ANDA |
| Application number | 064146 |
| Company | HOSPIRA |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | EQ 500MG BASE/100ML |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission status date | Apr 2, 1997 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- No FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: