Lowers the risk of undergoing coronary revascularization procedures and slow the…. ANDA 79011, held by Teva Pharms USA. Fluvastatin Sodium.
As of Nov 15, 2026, ANDA 79011 (Fluvastatin Sodium), held by Teva Pharms USA, was first approved by FDA on Jan 27, 2016, with 3 approved supplements and 0 published complete response letters.
Fluvastatin sodium extended-release tablets are indicated: To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluvastatin SodiumEQ 80MG BASE · tablet, extended release;oral | Fluvastatin Sodium | Rx |
| Sep 24, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 2, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 2, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 27, 2016 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
