FDA Orange Book · active-ingredient family
Levocarnitine
Levocarnitine: 3 brands, 11 generics; first approved Dec 27, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
11
Listed patents
0
Presentations
17
Brand (NDA) products
Originator applications
- LEADIANT BIOSCI INCNDA 0201821992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Rx AP - LEADIANT BIOSCI INCNDA 01925719862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML SOLUTION ORAL Rx AA 1GM/10ML SOLUTION ORAL Rx AA - LEADIANT BIOSCI INCNDA 01894819852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 330MG TABLET ORAL Rx AB 1GM/10ML SOLUTION ORAL Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- LEVOCARNITINEBAXTER HLTHCARE CORPANDA 2178962026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Rx AP - LEVOCARNITINEDEVA HOLDING ASANDA 2174302025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Rx AP - LEVOCARNITINENOVITIUM PHARMAANDA 2163842022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 330MG TABLET ORAL Rx AB - LEVOCARNITINESCIEGEN PHARMSANDA 2125332021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML SOLUTION ORAL Rx AA - LEVOCARNITINENOVITIUM PHARMAANDA 21167620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML SOLUTION ORAL Rx AA 1GM/10ML SOLUTION ORAL Rx AA - LEVOCARNITINEHIKMAANDA 0773992007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML SOLUTION ORAL Discontinued — - LEVOCARNITINERISINGANDA 0768582004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 330MG TABLET ORAL Rx AB - LEVOCARNITINERISINGANDA 0768512004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML SOLUTION ORAL Rx AA - LEVOCARNITINEAM REGENTANDA 0758612001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Rx AP - LEVOCARNITINEHIKMAANDA 0755672001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION Rx AP - LEVOCARNITINETEVA PHARMS USAANDA 0758812001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/ML INJECTABLE INJECTION 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
41 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1985–2026 across 14 FDA applications.
Brand (NDA) 321%
Generic (ANDA) 1179%
Levocarnitine: 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.
