atorvastatin / ezetimibe Oral Tablet

Brand(s)
Liptruzet
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2013-05-03
License(s)
NDA
RxNORM
ORAL TABLET\ATORVASTATIN:EZETIMIBE
FDAOB
ORAL\TABLET\ATORVASTATIN CALCIUM: EZETIMIBE
SPL Active
ORAL\TABLET, FILM COATED\ATORVASTATIN CALCIUM TRIHYDRATE: EZETIMIBE
SPL Moiety
ORAL\TABLET, FILM COATED\ATORVASTATIN: EZETIMIBE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1665820320LiptruzetNDAMerck Sharp & Dohme Corp.2013-05-03ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBEORALTABLET, FILM COATEDNDA200153c387354c-607b-474d-b2e5-d35c789ce09b

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1665820321LiptruzetNDAMerck Sharp & Dohme Corp.2013-05-03ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBEORALTABLET, FILM COATEDNDA200153c387354c-607b-474d-b2e5-d35c789ce09b

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1665820322LiptruzetNDAMerck Sharp & Dohme Corp.2013-05-03ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBEORALTABLET, FILM COATEDNDA200153c387354c-607b-474d-b2e5-d35c789ce09b

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1665820323LiptruzetNDAMerck Sharp & Dohme Corp.2013-05-03ATORVASTATIN CALCIUM TRIHYDRATE, EZETIMIBEORALTABLET, FILM COATEDNDA200153c387354c-607b-474d-b2e5-d35c789ce09b

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1NDA200153LIPTRUZETTrueMERCK SHARP AND DOHME CORP2013-05-03p5686104, FOR THE TREATMENT OF PRIMARY HYPERLIPIDEMIA, SUBSTANCE
p5969156
pRE42461, FOR THE TREATMENT OF PRIMARY HYPERLIPIDEMIA, SUBSTANCE
NEW COMBINATION [2016-05-03]NDA200153_001, NDA200153_002, NDA200153_003, NDA200153_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200153_001discontinuedEZETIMIBE (10MG), ATORVASTATIN CALCIUM (EQ 10MG BASE)ORALTABLETFalse2013-05-03LIPTRUZET
2NDA200153_002discontinuedEZETIMIBE (10MG), ATORVASTATIN CALCIUM (EQ 20MG BASE)ORALTABLETFalse2013-05-03LIPTRUZET
3NDA200153_003discontinuedATORVASTATIN CALCIUM (EQ 40MG BASE), EZETIMIBE (10MG)ORALTABLETFalse2013-05-03LIPTRUZET
4NDA200153_004discontinuedATORVASTATIN CALCIUM (EQ 80MG BASE), EZETIMIBE (10MG)ORALTABLETFalse2013-05-03LIPTRUZET

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5686104 (view patent)2014-11-11NDA200153, NDA020702, NDA021540Amlodipine / atorvastatin Oral Tablet
atorvastatin Oral Tablet
2p5969156 (view patent)2016-07-08NDA200153, NDA020702, NDA021540Amlodipine / atorvastatin Oral Tablet
atorvastatin Oral Tablet
3pRE42461 (view patent)2016-10-25NDA200153, NDA021445, NDA021687ezetimibe Oral Tablet
ezetimibe / Simvastatin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c387354c-607b-474d-b2e5-d35c789ce09b (view SPL)These highlights do not include all the information needed to use LIPTRUZET safely and effectively. See full prescribing information for LIPTRUZET. LIPTRUZET (ezetimibe and atorvastatin) tablets for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2013-09-096665820320, 665820321, 665820322, 665820323

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