Orange Book product · Brand (NDA)
CARNITOR
LEVOCARNITINE
At a glance
Apr 10, 1986
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 1986
40 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCARNITINE
Strength
1GM/10ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 019257
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1992CARNITORBrand (NDA)
NDA 020182 · LEADIANT BIOSCI INC
- 1988CARNITORBrand (NDA)
NDA 018948 · LEADIANT BIOSCI INC
- 2025LEVOCARNITINEGeneric (ANDA)
ANDA 217430 · DEVA HOLDING AS
- 2022LEVOCARNITINEGeneric (ANDA)
ANDA 216384 · NOVITIUM PHARMA
- 2021LEVOCARNITINEGeneric (ANDA)
ANDA 212533 · SCIEGEN PHARMS
- 2019LEVOCARNITINEGeneric (ANDA)
ANDA 211676 · NOVITIUM PHARMA
- 2007LEVOCARNITINEGeneric (ANDA)
ANDA 077399 · HIKMA
- 2004LEVOCARNITINEGeneric (ANDA)
ANDA 076858 · RISING
- 2004LEVOCARNITINEGeneric (ANDA)
ANDA 076851 · RISING
- 2001LEVOCARNITINEGeneric (ANDA)
ANDA 075861 · AM REGENT
- 2001LEVOCARNITINEGeneric (ANDA)
ANDA 075567 · HIKMA
- 2001LEVOCARNITINEGeneric (ANDA)
ANDA 075881 · TEVA PHARMS USA
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.
