Drug application
ROSZET (EZETIMIBE, ROSUVASTATIN CALCIUM)
Drugs@FDA NDA 213072 · ALTHERA PHARMS
Key facts
| Drug name | ROSZET |
|---|---|
| Active ingredients | EZETIMIBE, ROSUVASTATIN CALCIUM |
| Application type | NDA |
| Application number | 213072 |
| Company | ALTHERA PHARMS |
| Dosage forms | TABLET, ORAL |
| Strength | 10MG;EQ 5MG BASE |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Mar 23, 2021 |
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: