Drug application
OMEPRAZOLE (OMEPRAZOLE)
Drugs@FDA NDA 209400 · DEXCEL
Key facts
| Drug name | OMEPRAZOLE |
|---|---|
| Active ingredients | OMEPRAZOLE |
| Application type | NDA |
| Application number | 209400 |
| Company | DEXCEL |
| Dosage forms | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, ORAL |
| Strength | 20MG |
| Marketing status | Over-the-counter |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Jul 5, 2017 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 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: