fluvastatin Extended Release Oral Tablet

Brand(s)
Lescol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2012-10-31)
Oldest Current Product
2000-10-06
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\FLUVASTATIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\FLUVASTATIN SODIUM
SPL Active
ORAL\TABLET, EXTENDED RELEASE\FLUVASTATIN SODIUM
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\FLUVASTATIN SODIUM
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\FLUVASTATIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\FLUVASTATIN

product(s) by strength(s)

24 hr fluvastatin 80 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780354LescolNDANovartis Pharmaceuticals Corporation2000-10-06FLUVASTATIN SODIUMORALTABLET, EXTENDED RELEASENDA0211928a1823e7-26fb-4858-bac7-9e152e5ea16a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785121ANDAMylan Pharmaceuticals Inc.2015-09-11FLUVASTATIN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA2024584226222a-7729-42aa-8dff-887491a5dab7
2007815370NDA AUTHORIZED GENERICSandoz Inc2015-10-16FLUVASTATIN SODIUMORALTABLET, EXTENDED RELEASENDA021192dde8cf19-866e-4884-b582-de2730c7524e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684601LescolNDAPhysicians Total Care, Inc.2002-03-12FLUVASTATIN SODIUMORALTABLET, EXTENDED RELEASE000780354NDA0211920d466214-78a8-44cd-923c-c286a0f74f66
2681514471LescolNDACarilion Materials Management2000-10-06FLUVASTATIN SODIUMORALTABLET, EXTENDED RELEASE000780354NDA021192cd12fae6-f277-4679-a7a8-b98719fe6fa9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA202458FLUVASTATIN SODIUMMYLAN PHARMACEUTICALS INC2015-09-11ANDA202458_001
2NDA021192LESCOL XLNOVARTIS PHARMACEUTICALS CORP2000-10-06p6242003NDA021192_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202458_001RXFLUVASTATIN SODIUM (80MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-09-11FLUVASTATIN SODIUM
2NDA021192_001RXFLUVASTATIN SODIUM (80MG)ORALTABLET, EXTENDED RELEASETrueAB2000-10-06LESCOL XL

patent(s)

#idexpiration dateapplication(s)
1p6242003 (view patent)2020-04-13NDA021192

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10d466214-78a8-44cd-923c-c286a0f74f66 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-231548684601
24226222a-7729-42aa-8dff-887491a5dab7 (view SPL)These highlights do not include all the information needed to use fluvastatin sodium extended-release tablets safely and effectively. See full prescribing information for fluvastatin sodium extended-release tablets. Fluvastatin Sodium Extended-release Tablets for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-06-252003785121
38a1823e7-26fb-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 Corporation2012-10-3110000780354, 000780176, 000780234fluvastatin Oral Capsule
4cd12fae6-f277-4679-a7a8-b98719fe6fa9 (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 PrescriptionCarilion Materials ManagementREPACK2012-10-312681514471
5dde8cf19-866e-4884-b582-de2730c7524e (view SPL)These highlights do not include all the information needed to use Fluvastatin Sodium Extended-Release Tablets, USP safely and effectively. See full prescribing information for Fluvastatin Sodium Extended-Release Tablets, USPFluvastatin Sodium Extended-Release Tablets, USP for oral useInitial U.S. Approval: 1993/ 2000prescriptionHuman PrescriptionSandoz Inc2012-10-315007815370

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