Orange Book product · Brand (NDA)
LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
LEUCOVORIN CALCIUM
Strength
EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 008107
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2026VYKOURABrand (NDA)
NDA 220406 · AVYXA HOLDINGS
- 2025LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 218200 · GLAND
- 2023LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 216590 · MEITHEAL
- 2023LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 217021 · HAINAN POLY
- 2020LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 213929 · LEADING
- 2020LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 211132 · INGENUS PHARMS LLC
- 2018LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 210917 · INGENUS PHARMS LLC
- 2018LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 207226 · FRESENIUS KABI USA
- 2018LEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 207241 · FRESENIUS KABI USA
- 2017LEUCOVORIN CALCIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 209110 · SAGENT PHARMS INC
- 2017LEUCOVORIN CALCIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 203800 · MYLAN LABS LTD
- 2012LEUCOVORIN CALCIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 200753 · SAGENT PHARMS
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.
