Leucovorin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-10-31)
Oldest Current Product
1990-06-30
License(s)
ANDA
RxNORM
ORAL TABLET\LEUCOVORIN
FDAOB
ORAL\TABLET\LEUCOVORIN CALCIUM
SPL Active
ORAL\TABLET\LEUCOVORIN CALCIUM
SPL Moiety
ORAL\TABLET\LEUCOVORIN

product(s) by strength(s)

leucovorin 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544497ANDARoxane Laboratories, Inc1993-02-22LEUCOVORIN CALCIUMORALTABLETANDA07273433663425-4731-4977-9127-9e59b6b91497

leucovorin 15 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544498ANDARoxane Laboratories, Inc1993-02-22LEUCOVORIN CALCIUMORALTABLETANDA07273533663425-4731-4977-9127-9e59b6b91497

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685915ANDAPhysicians Total Care, Inc.2008-07-08LEUCOVORIN CALCIUMORALTABLET000548498ANDA072735084227c1-90eb-4653-807a-eb98cb3cefb8

leucovorin 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544499ANDARoxane Laboratories, Inc1993-02-22LEUCOVORIN CALCIUMORALTABLETANDA07273633663425-4731-4977-9127-9e59b6b91497
2005550485ANDABarr Laboratories Inc.1990-06-30LEUCOVORIN CALCIUMORALTABLETANDA07119994669fc8-3c1c-4228-be27-09a1cd468c36
3510790582ANDAMylan Institutional Inc.1997-08-27LEUCOVORIN CALCIUMORALTABLETANDA07119955f7b797-eebd-4da5-a383-173c694e631e

leucovorin 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544496ANDARoxane Laboratories, Inc1993-02-22LEUCOVORIN CALCIUMORALTABLETANDA07273333663425-4731-4977-9127-9e59b6b91497
2000548496ANDARoxane Laboratories, Inc1993-02-22LEUCOVORIN CALCIUMORALTABLETANDA07273333663425-4731-4977-9127-9e59b6b91497
3005550484ANDABarr Laboratories Inc.1990-06-30LEUCOVORIN CALCIUMORALTABLETANDA07119894669fc8-3c1c-4228-be27-09a1cd468c36
4510790581ANDAMylan Institutional Inc.1996-02-26LEUCOVORIN CALCIUMORALTABLETANDA07119855f7b797-eebd-4da5-a383-173c694e631e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250018ANDARemedyrepack Inc.2013-09-27LEUCOVORIN CALCIUMORALTABLET005550484ANDA0711980d7b9bc1-dc00-4665-bd18-64fcf12efbfb
2521250453ANDARemedyrepack Inc.2013-05-22LEUCOVORIN CALCIUMORALTABLET005550484ANDA07119841956b57-23a4-4c10-8078-a177c7cb7212
3548683310ANDAPhysicians Total Care, Inc.2002-04-15LEUCOVORIN CALCIUMORALTABLET000544496ANDA072733084227c1-90eb-4653-807a-eb98cb3cefb8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071104LEUCOVORIN CALCIUMTrueXANODYNE PHARMACEUTICS INC1987-03-04ANDA071104_001
2ANDA071198LEUCOVORIN CALCIUMBARR PHARMACEUTICALS1987-09-24ANDA071198_001
3ANDA071199LEUCOVORIN CALCIUMBARR PHARMACEUTICALS1987-09-24ANDA071199_001
4ANDA071598LEUCOVORIN CALCIUMTruePAR PHARMACEUTICAL INC1987-10-14ANDA071598_001
5ANDA071600LEUCOVORIN CALCIUMTruePAR PHARMACEUTICAL INC1987-10-14ANDA071600_001
6ANDA071962LEUCOVORIN CALCIUMTrueXANODYNE PHARMACEUTICS INC1987-11-19ANDA071962_001
7ANDA072733LEUCOVORIN CALCIUMROXANE LABORATORIES INC1993-02-22ANDA072733_001
8ANDA072734LEUCOVORIN CALCIUMROXANE LABORATORIES INC1993-02-22ANDA072734_001
9ANDA072735LEUCOVORIN CALCIUMROXANE LABORATORIES INC1993-02-22ANDA072735_001
10ANDA072736LEUCOVORIN CALCIUMROXANE LABORATORIES INC1993-02-22ANDA072736_001
11ANDA073099LEUCOVORIN CALCIUMTruePHARMACHEMIE BV1997-03-28ANDA073099_001
12ANDA073101LEUCOVORIN CALCIUMTruePHARMACHEMIE BV1997-03-28ANDA073101_001
13ANDA074544LEUCOVORIN CALCIUMTrueCOREPHARMA LLC1997-08-28ANDA074544_001, ANDA074544_002
14ANDA075327LEUCOVORIN CALCIUMTrueSANDOZ INC1999-03-24ANDA075327_001
15NDA018342WELLCOVORINTrueGLAXOSMITHKLINE1983-07-08NDA018342_001, NDA018342_002
16NDA018459LEUCOVORIN CALCIUMTrueXANODYNE PHARMACEUTICS INC1986-01-30NDA018459_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071104_001discontinuedLEUCOVORIN CALCIUM (EQ 15MG BASE)ORALTABLETFalse1987-03-04LEUCOVORIN CALCIUM
2ANDA071198_001RXLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalseAB1987-09-24LEUCOVORIN CALCIUM
3ANDA071199_001RXLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETFalseAB1987-09-24LEUCOVORIN CALCIUM
4ANDA071598_001discontinuedLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETFalse1987-10-14LEUCOVORIN CALCIUM
5ANDA071600_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalse1987-10-14LEUCOVORIN CALCIUM
6ANDA071962_001discontinuedLEUCOVORIN CALCIUM (EQ 10MG BASE)ORALTABLETFalse1987-11-19LEUCOVORIN CALCIUM
7ANDA072733_001RXLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalseAB1993-02-22LEUCOVORIN CALCIUM
8ANDA072734_001RXLEUCOVORIN CALCIUM (EQ 10MG BASE)ORALTABLETFalse1993-02-22LEUCOVORIN CALCIUM
9ANDA072735_001RXLEUCOVORIN CALCIUM (EQ 15MG BASE)ORALTABLETFalseAB1993-02-22LEUCOVORIN CALCIUM
10ANDA072736_001RXLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETTrueAB1993-02-22LEUCOVORIN CALCIUM
11ANDA073099_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalse1997-03-28LEUCOVORIN CALCIUM
12ANDA073101_001discontinuedLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETFalse1997-03-28LEUCOVORIN CALCIUM
13ANDA074544_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalse1997-08-28LEUCOVORIN CALCIUM
14ANDA074544_002discontinuedLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETFalse1997-08-28LEUCOVORIN CALCIUM
15ANDA075327_001discontinuedLEUCOVORIN CALCIUM (EQ 15MG BASE)ORALTABLETFalse1999-03-24LEUCOVORIN CALCIUM
16NDA018342_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalse1983-07-08WELLCOVORIN
17NDA018342_002discontinuedLEUCOVORIN CALCIUM (EQ 25MG BASE)ORALTABLETFalse1983-07-08WELLCOVORIN
18NDA018459_001discontinuedLEUCOVORIN CALCIUM (EQ 5MG BASE)ORALTABLETFalse1986-01-30LEUCOVORIN CALCIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1084227c1-90eb-4653-807a-eb98cb3cefb8 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-022548683310, 548685915
20d7b9bc1-dc00-4665-bd18-64fcf12efbfb (view SPL)LEUCOVORIN CALCIUM TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-271521250018
333663425-4731-4977-9127-9e59b6b91497 (view SPL)Leucovorin Calcium Tablets USP, 5 mg, 10 mg, 15 mg, and 25 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-10-316000544496, 000544497, 000544498, 000544499, 000548496
441956b57-23a4-4c10-8078-a177c7cb7212 (view SPL)LEUCOVORIN CALCIUM TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-221521250453
555f7b797-eebd-4da5-a383-173c694e631e (view SPL)LEUCOVORIN CALCIUM TABLETS USPprescriptionHuman PrescriptionMylan Institutional Inc.2014-02-073510790581, 510790582
694669fc8-3c1c-4228-be27-09a1cd468c36 (view SPL)LEUCOVORIN CALCIUM TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-09-135005550484, 005550485

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