fluvastatin Oral Capsule

Brand(s)
Lescol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2012-10-31)
Oldest Current Product
1993-12-30
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\FLUVASTATIN
FDAOB
ORAL\CAPSULE\FLUVASTATIN SODIUM
SPL Active
ORAL\CAPSULE\FLUVASTATIN SODIUM
SPL Moiety
ORAL\CAPSULE\FLUVASTATIN

product(s) by strength(s)

fluvastatin 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780176LescolNDANovartis Pharmaceuticals Corporation1993-12-30FLUVASTATIN SODIUMORALCAPSULENDA0202618a1823e7-26fb-4858-bac7-9e152e5ea16a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937442ANDATeva Pharmaceuticals Usa Inc2012-07-05FLUVASTATIN SODIUMORALCAPSULEANDA078407aad8b373-0aec-4efb-8e61-3d8114b31127
2003788020ANDAMylan Pharmaceuticals Inc.2013-03-19FLUVASTATIN SODIUMORALCAPSULEANDA090595d0a7247c-5d83-4bc1-840f-c58314d14195

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683329LescolNDAPhysicians Total Care, Inc.1994-06-10FLUVASTATIN SODIUMORALCAPSULE000780176NDA020261e38126a5-9d6a-422f-812c-a01610108162
2681511326ANDACarilion Materials Management2013-03-19FLUVASTATIN SODIUMORALCAPSULE003788020ANDA090595e2dddb57-aea3-45f2-ad06-2b209a8d934b

fluvastatin 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780234LescolNDANovartis Pharmaceuticals Corporation1993-12-30FLUVASTATIN SODIUMORALCAPSULENDA0202618a1823e7-26fb-4858-bac7-9e152e5ea16a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937443ANDATeva Pharmaceuticals Usa Inc2012-07-05FLUVASTATIN SODIUMORALCAPSULEANDA078407aad8b373-0aec-4efb-8e61-3d8114b31127
2003788021ANDAMylan Pharmaceuticals Inc.2013-03-19FLUVASTATIN SODIUMORALCAPSULEANDA090595d0a7247c-5d83-4bc1-840f-c58314d14195

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684224LescolNDAPhysicians Total Care, Inc.2002-03-08FLUVASTATIN SODIUMORALCAPSULE000780234NDA020261e38126a5-9d6a-422f-812c-a01610108162
2681511334ANDACarilion Materials Management2013-03-19FLUVASTATIN SODIUMORALCAPSULE003788021ANDA090595f0674ec5-22b9-4ab9-a118-54c83cda3ec2

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078407FLUVASTATIN SODIUMTEVA PHARMACEUTICALS USA2012-06-12ANDA078407_001, ANDA078407_002
2ANDA090595FLUVASTATIN SODIUMMYLAN PHARMACEUTICALS INC.2012-04-11ANDA090595_001, ANDA090595_002
3NDA020261LESCOLNOVARTIS PHARMACEUTICALS CORP1993-12-31NDA020261_001, NDA020261_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078407_001RXFLUVASTATIN SODIUM (EQ 20MG BASE)ORALCAPSULEFalseAB2012-06-12FLUVASTATIN SODIUM
2ANDA078407_002RXFLUVASTATIN SODIUM (EQ 40MG BASE)ORALCAPSULEFalseAB2012-06-12FLUVASTATIN SODIUM
3ANDA090595_001RXFLUVASTATIN SODIUM (EQ 20MG BASE)ORALCAPSULEFalseAB2012-04-11FLUVASTATIN SODIUM
4ANDA090595_002RXFLUVASTATIN SODIUM (EQ 40MG BASE)ORALCAPSULEFalseAB2012-04-11FLUVASTATIN SODIUM
5NDA020261_001RXFLUVASTATIN SODIUM (EQ 20MG BASE)ORALCAPSULEFalseAB1993-12-31LESCOL
6NDA020261_002RXFLUVASTATIN SODIUM (EQ 40MG BASE)ORALCAPSULETrueAB1993-12-31LESCOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
18a1823e7-26fb-4858-bac7-9e152e5ea16a (view SPL)These highlights do not include all the information needed to use Lescol / Lescol XL safely and effectively. See full prescribing information for Lescol / Lescol XL. Lescol (fluvastatin sodium) capsules/ Lescol XL (fluvastatin sodium) extended-release tablets for oral use Initial U.S. Approval: 1993/ 2000prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2012-10-3110000780176, 000780234, 000780354fluvastatin Extended Release Oral Tablet
2aad8b373-0aec-4efb-8e61-3d8114b31127 (view SPL)These highlights do not include all the information needed to use fluvastatin capsules USP safely and effectively. See full prescribing information for fluvastatin capsules USP. FLUVASTATIN capsules USP for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-11-014000937442, 000937443
3d0a7247c-5d83-4bc1-840f-c58314d14195 (view SPL)These highlights do not include all the information needed to use fluvastatin capsules safely and effectively. See full prescribing information for fluvastatin capsules.Fluvastatin Capsules, USP for oral useInitial U.S. Approval: 1993prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-01-254003788020, 003788021
4e2dddb57-aea3-45f2-ad06-2b209a8d934b (view SPL)These highlights do not include all the information needed to use fluvastatin capsules safely and effectively. See full prescribing information for fluvastatin capsules. Fluvastatin Capsules, USP for oral use Initial U.S. Approval: 1993prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-01-252681511326
5e38126a5-9d6a-422f-812c-a01610108162 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-231548683329, 548684224
6f0674ec5-22b9-4ab9-a118-54c83cda3ec2 (view SPL)These highlights do not include all the information needed to use fluvastatin capsules safely and effectively. See full prescribing information for fluvastatin capsules. Fluvastatin Capsules, USP for oral use Initial U.S. Approval: 1993prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-01-252681511334

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