Leucovorin Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sagent Pharmaceuticals (2014-09-26)
Oldest Current Product
1994-02-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\LEUCOVORIN
FDAOB
INJECTION\INJECTION\LEUCOVORIN CALCIUM\rdfq
ORAL\FOR SOLUTION\LEUCOVORIN CALCIUM
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\LEUCOVORIN CALCIUM
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEUCOVORIN CALCIUM
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\LEUCOVORIN
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEUCOVORIN
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEUCOVORIN: LEUCOVORIN CALCIUM

product(s) by strength(s)

leucovorin 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007035140ANDATeva Parenteral Medicines, Inc1994-02-01LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA081277886aeb54-2abf-4ca5-8a0d-4d881b2e46a9
2250210813ANDASagent Pharmaceuticals2012-09-15, 2013-12-01LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA2007533be94523-f6d6-4b25-82b0-3e0d021594c5, 9d0e5356-ff39-4a8e-944c-e808a21ef4b2
3250210814ANDASagent Pharmaceuticals2012-09-15, 2013-12-01LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA2007533be94523-f6d6-4b25-82b0-3e0d021594c5, 9d0e5356-ff39-4a8e-944c-e808a21ef4b2
4250210815ANDASagent Pharmaceuticals2012-09-15, 2013-12-01LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA2007533be94523-f6d6-4b25-82b0-3e0d021594c5, 9d0e5356-ff39-4a8e-944c-e808a21ef4b2
5633230710ANDAApp Pharmaceuticals, Llc2010-09-18LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA040258ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c, e3b957dc-a542-4f69-b8a0-7df401ee706f
6633230711ANDAApp Pharmaceuticals, Llc2010-09-18LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA040286e3b957dc-a542-4f69-b8a0-7df401ee706f

leucovorin 20 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007035145ANDATeva Parenteral Medicines, Inc1997-06-12LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0401742c492234-2d6d-414d-aec6-387cc1937eb5, 886aeb54-2abf-4ca5-8a0d-4d881b2e46a9
2250210816ANDASagent Pharmaceuticals2012-09-15, 2013-12-01LEUCOVORIN CALCIUMINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA2008553be94523-f6d6-4b25-82b0-3e0d021594c5, 9d0e5356-ff39-4a8e-944c-e808a21ef4b2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040056LEUCOVORIN CALCIUM PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL1995-05-23ANDA040056_001
2ANDA040147LEUCOVORIN CALCIUM PRESERVATIVE FREETrueHOSPIRA INC1997-06-25ANDA040147_001
3ANDA040174LEUCOVORIN CALCIUMTEVA PHARMACEUTICALS USA1997-06-12ANDA040174_001
4ANDA040258LEUCOVORIN CALCIUM PRESERVATIVE FREEFRESENIUS KABI USA LLC1999-02-26ANDA040258_001
5ANDA040262LEUCOVORIN CALCIUMTruePHARMACHEMIE BV1999-12-15ANDA040262_001
6ANDA040286LEUCOVORIN CALCIUM PRESERVATIVE FREEFRESENIUS KABI USA LLC1999-02-26ANDA040286_001
7ANDA040332LEUCOVORIN CALCIUM PRESERVATIVE FREETrueTEVA PARENTERAL MEDICINES INC1999-06-28ANDA040332_001
8ANDA040335LEUCOVORIN CALCIUM PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL2000-04-20ANDA040335_001
9ANDA040338LEUCOVORIN CALCIUM PRESERVATIVE FREETrueLUITPOLD PHARMACEUTICALS INC2001-01-31ANDA040338_001
10ANDA040347LEUCOVORIN CALCIUM PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL2000-04-25ANDA040347_001
11ANDA070480LEUCOVORIN CALCIUMTrueELKINS SINN DIV AH ROBINS CO INC1987-01-02ANDA070480_001
12ANDA081224LEUCOVORIN CALCIUMTrueELKINS SINN DIV AH ROBINS CO INC1994-06-03ANDA081224_001
13ANDA081277LEUCOVORIN CALCIUMTEVA PHARMACEUTICALS USA1993-09-28ANDA081277_001
14ANDA081278LEUCOVORIN CALCIUMTrueTEVA PARENTERAL MEDICINES INC1993-09-28ANDA081278_001
15ANDA087439WELLCOVORINTrueGLAXOSMITHKLINE1982-10-19ANDA087439_001
16ANDA088939LEUCOVORIN CALCIUMTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-12-01ANDA088939_001
17ANDA089352LEUCOVORIN CALCIUMTrueABIC LTD1988-06-01ANDA089352_001
18ANDA089353LEUCOVORIN CALCIUMTrueABIC LTD1988-06-01ANDA089353_001
19ANDA089384LEUCOVORIN CALCIUMEUROHEALTH INTERNATIONAL SARL1987-09-14ANDA089384_001
20ANDA089465WELLCOVORINTrueGLAXOSMITHKLINE1989-01-23ANDA089465_001
21ANDA089628LEUCOVORIN CALCIUMTruePHARMACHEMIE USA INC1997-04-17ANDA089628_001
22ANDA089717LEUCOVORIN CALCIUMEUROHEALTH INTERNATIONAL SARL1988-03-28ANDA089717_001
23ANDA089833WELLCOVORINTrueGLAXOSMITHKLINE1989-01-23ANDA089833_001
24ANDA089834WELLCOVORINTrueGLAXOSMITHKLINE1989-01-23ANDA089834_001
25ANDA089915LEUCOVORIN CALCIUMTruePHARMACHEMIE USA INC1997-04-17ANDA089915_001
26ANDA200753LEUCOVORIN CALCIUM PRESERVATIVE FREESAGENT PHARMACEUTICALS INC2012-09-06ANDA200753_001, ANDA200753_002, ANDA200753_003
27ANDA200855LEUCOVORIN CALCIUM PRESERVATIVE FREESAGENT PHARMACEUTICALS INC2012-09-06ANDA200855_001
28NDA008107LEUCOVORIN CALCIUMTrueHOSPIRA INCNDA008107_001, NDA008107_002, NDA008107_003, NDA008107_004, NDA008107_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040056_001RXLEUCOVORIN CALCIUM (EQ 200MG BASE/VIAL)INJECTIONTrueAP1995-05-23LEUCOVORIN CALCIUM PRESERVATIVE FREE
2ANDA040147_001discontinuedLEUCOVORIN CALCIUM (EQ 10MG BASE/ML)INJECTIONFalse1997-06-25LEUCOVORIN CALCIUM PRESERVATIVE FREE
3ANDA040174_001RXLEUCOVORIN CALCIUM (EQ 350MG BASE/VIAL)INJECTIONFalseAP1997-06-12LEUCOVORIN CALCIUM
4ANDA040258_001RXLEUCOVORIN CALCIUM (EQ 200MG BASE/VIAL)INJECTIONFalseAP1999-02-26LEUCOVORIN CALCIUM PRESERVATIVE FREE
5ANDA040262_001discontinuedLEUCOVORIN CALCIUM (EQ 350MG BASE/VIAL)INJECTIONFalse1999-12-15LEUCOVORIN CALCIUM
6ANDA040286_001RXLEUCOVORIN CALCIUM (EQ 500MG BASE/VIAL)INJECTIONTrue1999-02-26LEUCOVORIN CALCIUM PRESERVATIVE FREE
7ANDA040332_001discontinuedLEUCOVORIN CALCIUM (EQ 10MG BASE/ML)INJECTIONFalse1999-06-28LEUCOVORIN CALCIUM PRESERVATIVE FREE
8ANDA040335_001RXLEUCOVORIN CALCIUM (EQ 350MG BASE/VIAL)INJECTIONTrueAP2000-04-20LEUCOVORIN CALCIUM PRESERVATIVE FREE
9ANDA040338_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse2001-01-31LEUCOVORIN CALCIUM PRESERVATIVE FREE
10ANDA040347_001RXLEUCOVORIN CALCIUM (EQ 10MG BASE/ML)INJECTIONTrue2000-04-25LEUCOVORIN CALCIUM PRESERVATIVE FREE
11ANDA070480_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1987-01-02LEUCOVORIN CALCIUM
12ANDA081224_001discontinuedLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalse1994-06-03LEUCOVORIN CALCIUM
13ANDA081277_001RXLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalseAP1993-09-28LEUCOVORIN CALCIUM
14ANDA081278_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1993-09-28LEUCOVORIN CALCIUM
15ANDA087439_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE/ML)INJECTIONFalse1982-10-19WELLCOVORIN
16ANDA088939_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1986-12-01LEUCOVORIN CALCIUM
17ANDA089352_001discontinuedLEUCOVORIN CALCIUM (EQ 3MG BASE/ML)INJECTIONFalse1988-06-01LEUCOVORIN CALCIUM
18ANDA089353_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1988-06-01LEUCOVORIN CALCIUM
19ANDA089384_001RXLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONTrueAP1987-09-14LEUCOVORIN CALCIUM
20ANDA089465_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1989-01-23WELLCOVORIN
21ANDA089628_001discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalse1997-04-17LEUCOVORIN CALCIUM
22ANDA089717_001RXLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONTrueAP1988-03-28LEUCOVORIN CALCIUM
23ANDA089833_001discontinuedLEUCOVORIN CALCIUM (EQ 25MG BASE/VIAL)INJECTIONFalse1989-01-23WELLCOVORIN
24ANDA089834_001discontinuedLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalse1989-01-23WELLCOVORIN
25ANDA089915_001discontinuedLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalse1997-04-17LEUCOVORIN CALCIUM
26ANDA200753_001RXLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalseAP2012-09-06LEUCOVORIN CALCIUM PRESERVATIVE FREE
27ANDA200753_002RXLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalseAP2012-09-06LEUCOVORIN CALCIUM PRESERVATIVE FREE
28ANDA200753_003RXLEUCOVORIN CALCIUM (EQ 200MG BASE/VIAL)INJECTIONFalseAP2012-09-06LEUCOVORIN CALCIUM PRESERVATIVE FREE
29ANDA200855_001RXLEUCOVORIN CALCIUM (EQ 350MG BASE/VIAL)INJECTIONFalseAP2012-09-06LEUCOVORIN CALCIUM PRESERVATIVE FREE
30NDA008107_001discontinuedLEUCOVORIN CALCIUM (EQ 3MG BASE/ML)INJECTIONFalseLEUCOVORIN CALCIUM
31NDA008107_002discontinuedLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)INJECTIONFalseLEUCOVORIN CALCIUM
32NDA008107_003discontinuedLEUCOVORIN CALCIUM (EQ 60MG BASE/VIAL)ORALFOR SOLUTIONFalse1987-01-30LEUCOVORIN CALCIUM
33NDA008107_004discontinuedLEUCOVORIN CALCIUM (EQ 100MG BASE/VIAL)INJECTIONFalse1988-05-23LEUCOVORIN CALCIUM
34NDA008107_005discontinuedLEUCOVORIN CALCIUM (EQ 350MG BASE/VIAL)INJECTIONFalse1989-04-05LEUCOVORIN CALCIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12c492234-2d6d-414d-aec6-387cc1937eb5 (view SPL)Leucovorin Calcium for InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-02-192007035145
23be94523-f6d6-4b25-82b0-3e0d021594c5 (view SPL)Leucovorin Calcium for Injection(For IV or IM Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-263250210813, 250210814, 250210815, 250210816
3886aeb54-2abf-4ca5-8a0d-4d881b2e46a9 (view SPL)Leucovorin Calcium for InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-02-195007035140, 007035145
49d0e5356-ff39-4a8e-944c-e808a21ef4b2 (view SPL)Leucovorin Calcium for Injection(For IV or IM Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2014-09-265250210813, 250210814, 250210815, 250210816
5ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c (view SPL)Leucovorin Calcium for InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-05-211633230710
6e3b957dc-a542-4f69-b8a0-7df401ee706f (view SPL)Leucovorin Calcium For InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-02-232633230710, 633230711

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII