Is there a generic for Levoleucovorin calcium?

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Levoleucovorin calcium, referencing the brand LEVOLEUCOVORIN CALCIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Levoleucovorin calcium?

LEVOLEUCOVORIN CALCIUM (NDA 208723, ACTAVIS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Levoleucovorin calcium are approved?

Levoleucovorin calcium is approved in the following dosage forms: powder, solution.

FDA Orange Book · active-ingredient family

Levoleucovorin calcium

Levoleucovorin calcium: 2 brands, 12 generics; first approved Mar 07, 2008; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 12 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

LEVOLEUCOVORIN CALCIUMRLD

ACTAVIS LLCNDA 2087232016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

FUSILEVRLD

ACROTECH BIOPHARMANDA 02014020083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	INTRAVENOUS	Discontinued	—
EQ 250MG BASE/25ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	INTRAVENOUS	Discontinued	—

Abbreviated applications

Generic (ANDA) products (12)

LEVOLEUCOVORIN CALCIUM

HAINAN POLY PHARMANDA 21731420232 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

LEVOLEUCOVORIN CALCIUM

PRAXGENANDA 2137972021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

MEITHEALANDA 2110032019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUMRS

MEITHEALANDA 21100220192 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

GLANDANDA 21089220182 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

LEVOLEUCOVORIN CALCIUM

INGENUS PHARMS LLCANDA 21062320182 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

AMNEALANDA 2075482017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

ACTAVIS LLCANDA 2065162017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

AMNEALANDA 2075472017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

HIKMAANDA 2062632016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/VIAL	POWDER	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

PHARMOBEDIENTANDA 20357620152 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

LEVOLEUCOVORIN CALCIUM

SANDOZANDA 20356320152 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

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

Mar 07, 2008

18 yr 7 mo ago

Most recent approval

May 22, 2023

3 yr 2 mo ago

Approvals span 2008–2023 across 14 FDA applications.

Brand (NDA) 214%

Generic (ANDA) 1286%

Levoleucovorin calcium — 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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