Is there a generic for Fluvastatin sodium?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Fluvastatin sodium, referencing the brand LESCOL XL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluvastatin sodium?

LESCOL XL (NDA 021192, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fluvastatin sodium are approved?

Fluvastatin sodium is approved in the following dosage forms: capsule, tablet, extended release.

FDA Orange Book · active-ingredient family

Fluvastatin sodium

Fluvastatin sodium: 2 brands, 5 generics; first approved Dec 31, 1993; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

LESCOL XLRLDRS

SANDOZNDA 0211922000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

LESCOLRLD

NOVARTISNDA 02026119932 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

FLUVASTATIN SODIUM

BEIJINGANDA 2093972021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

FLUVASTATIN SODIUM

TEVA PHARMS USAANDA 0790112016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

FLUVASTATIN SODIUM

PHARMOBEDIENTANDA 2024582015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 80MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

FLUVASTATIN SODIUM

TEVA PHARMSANDA 07840720122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE	ORAL	Rx	AB
EQ 40MG BASE	CAPSULE	ORAL	Rx	AB

FLUVASTATIN SODIUM

MYLAN PHARMS INCANDA 09059520122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20MG BASE	CAPSULE	ORAL	Rx	AB
EQ 40MG BASE	CAPSULE	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Dec 31, 1993

33 yr ago

Most recent approval

Apr 26, 2021

5 yr 3 mo ago

Approvals span 1993–2021 across 7 FDA applications.

Brand (NDA) 229%

Generic (ANDA) 571%

Fluvastatin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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