Orange Book product
FLUVASTATIN SODIUM EQ 80MG BASE
Orange Book ANDA 079011 · TEVA PHARMACEUTICALS USA · Prescription
Key facts
| Proprietary name | FLUVASTATIN SODIUM |
|---|---|
| Active ingredients | FLUVASTATIN SODIUM |
| Strength | EQ 80MG BASE |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA079011 |
| Applicant holder | TEVA PHARMACEUTICALS USA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 27, 2016 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.