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Active ingredient

Fluvastatin

13 finished FDA listings contain Fluvastatin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FLUVASTATIN SODIUM
Dosage forms
Capsule, Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
5
Strengths listed
20 mg/1 · 40 mg/1 · 80 mg/1
Brand names in FDA listings
Fluvastatin Sodium, Fluvastatin Sodium Er, Lescol Xl

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 41127

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021192SANDOZ2000-10-062
ANDA 090595MYLAN PHARMS INC2012-04-112
ANDA 078407TEVA PHARMS2012-06-127
ANDA 079011TEVA PHARMS USA2016-01-271
ANDA 209397BEIJING2021-04-261

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.