Orange Book product · Generic (ANDA)
LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM
At a glance
Jul 27, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2018
8 yr ago
Today
Pharmaceutical detail
Active ingredient
LEUCOVORIN CALCIUM
Strength
EQ 500MG BASE/50ML (EQ 10MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
Not listed
Application
ANDA 207226
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of LEUCOVORIN CALCIUM
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ANDA 211132 · INGENUS PHARMS LLC
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ANDA 210917 · INGENUS PHARMS LLC
- 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.
