Application 200153

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPTRUZETATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002LIPTRUZETATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003LIPTRUZETATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004LIPTRUZETATORVASTATIN CALCIUM; EZETIMIBETABLET;ORALEQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80051SUPPL 2024-10-30
80050SUPPL 2024-10-30
80049SUPPL 2024-10-30
80046SUPPL 2024-10-29
80045SUPPL 2024-10-29
80044SUPPL 2024-10-29
64718SUPPL2020-09-29
64705SUPPL2020-09-28
49894SUPPL2017-09-29
49880SUPPL2017-09-29
49280SUPPL2017-08-08
49271SUPPL2017-08-08
32008SUPPL2014-05-20
40004SUPPL2014-05-19
44819ORIG2013-10-03
43341ORIG2013-10-03
18946ORIG2013-05-09
9796ORIG2013-05-07