Orange Book product · Generic (ANDA)
LEVOLEUCOVORIN CALCIUM
LEVOLEUCOVORIN CALCIUM
At a glance
Aug 16, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOLEUCOVORIN CALCIUM
Strength
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 211002
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of LEVOLEUCOVORIN CALCIUM
- 2016LEVOLEUCOVORIN CALCIUMBrand (NDA)
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- 2008FUSILEVBrand (NDA)
NDA 020140 · ACROTECH BIOPHARMA
- 2023LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 217314 · HAINAN POLY PHARM
- 2021LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 213797 · PRAXGEN
- 2019LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 211003 · MEITHEAL
- 2018LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 210892 · GLAND
- 2018LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 210623 · INGENUS PHARMS LLC
- 2017LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 207548 · AMNEAL
- 2017LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 206516 · ACTAVIS LLC
- 2017LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 207547 · AMNEAL
- 2016LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 206263 · HIKMA
- 2015LEVOLEUCOVORIN CALCIUMGeneric (ANDA)
ANDA 203576 · PHARMOBEDIENT
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.
