Drug application
LESCOL XL (FLUVASTATIN SODIUM)
Drugs@FDA NDA 021192 · SANDOZ
Key facts
| Drug name | LESCOL XL |
|---|---|
| Active ingredients | FLUVASTATIN SODIUM |
| Application type | NDA |
| Application number | 021192 |
| Company | SANDOZ |
| Dosage forms | TABLET, EXTENDED RELEASE, ORAL |
| Strength | EQ 80MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Oct 6, 2000 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 1–9 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: