Drug application
ACIPHEX (RABEPRAZOLE SODIUM)
Drugs@FDA NDA 021456 · EISAI MEDCL RES
Key facts
| Drug name | ACIPHEX |
|---|---|
| Active ingredients | RABEPRAZOLE SODIUM |
| Application type | NDA |
| Application number | 021456 |
| Company | EISAI MEDCL RES |
| Dosage forms | Tablet, Delayed Release, Oral |
| Strength | 20MG |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 6 - New Indication (no longer used) |
| Latest submission status date | Nov 8, 2002 |
At a glance
- 1–9 Submissions
- 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: