Drug application
NEXIUM IV (ESOMEPRAZOLE SODIUM)
Drugs@FDA NDA 021689 · ASTRAZENECA
Key facts
| Drug name | NEXIUM IV |
|---|---|
| Active ingredients | ESOMEPRAZOLE SODIUM |
| Application type | NDA |
| Application number | 021689 |
| Company | ASTRAZENECA |
| Dosage forms | INJECTABLE, INTRAVENOUS |
| Strength | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |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 | Mar 31, 2005 |
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: