Application 019574

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THALITONECHLORTHALIDONETABLET;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002THALITONECHLORTHALIDONETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-024THALITONEchlorthalidoneMonarch Pharmaceuticals, IncNDACurrent
70199-001ThalitonechlorthalidoneCasper Pharma LLCNDACurrent
70199-017ThalitoneChlorthalidoneCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60031SUPPL2019-09-18
60030SUPPL2019-09-18
53825SUPPL2018-04-27
1395SUPPL2004-06-07