Drug application
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (MOXIFLOXACIN HYDROCHLORIDE)
Drugs@FDA NDA 021277 · BAYER HLTHCARE
Key facts
| Drug name | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | MOXIFLOXACIN HYDROCHLORIDE |
| Application type | NDA |
| Application number | 021277 |
| Company | BAYER HLTHCARE |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Nov 30, 2001 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes 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: