Orange Book product · Generic (ANDA)
LEVOCARNITINE
LEVOCARNITINE
At a glance
Dec 09, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 2022
3 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCARNITINE
Strength
330MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 216384
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEVOCARNITINE
- 1992CARNITORBrand (NDA)
NDA 020182 · LEADIANT BIOSCI INC
- 1988CARNITORBrand (NDA)
NDA 018948 · LEADIANT BIOSCI INC
- 1986CARNITORBrand (NDA)
NDA 019257 · LEADIANT BIOSCI INC
- 2025LEVOCARNITINEGeneric (ANDA)
ANDA 217430 · DEVA HOLDING AS
- 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.
