Fluvastatin Sodium

ANDA 202458, held by Pharmobedient. Fluvastatin Sodium.

As of Nov 15, 2026, ANDA 202458 (Fluvastatin Sodium), held by Pharmobedient, was first approved by FDA on Sep 11, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2015
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 11, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluvastatin SodiumEQ 80MG BASE · tablet, extended release;oral	Fluvastatin Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 20, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jul 20, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Sep 11, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202458
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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