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)
2
Generics (ANDA)
12
Listed patents
0
Presentations
22
Brand (NDA) products
Originator applications
- LEVOLEUCOVORIN CALCIUMRLDACTAVIS LLCNDA 2087232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 175MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FUSILEVRLDACROTECH 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) SOLUTION INTRAVENOUS Discontinued — EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- LEVOLEUCOVORIN CALCIUMHAINAN 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 CALCIUMPRAXGENANDA 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 CALCIUMMEITHEALANDA 2110032019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - LEVOLEUCOVORIN CALCIUMRSMEITHEALANDA 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 CALCIUMGLANDANDA 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 CALCIUMINGENUS 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 CALCIUMAMNEALANDA 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 CALCIUMACTAVIS LLCANDA 2065162017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - LEVOLEUCOVORIN CALCIUMAMNEALANDA 2075472017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - LEVOLEUCOVORIN CALCIUMHIKMAANDA 2062632016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - LEVOLEUCOVORIN CALCIUMPHARMOBEDIENTANDA 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 CALCIUMSANDOZANDA 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 —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
18 yr 11 mo ago
Most recent approval
3 yr 5 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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