Application 018207

Type
NDA
Sponsor
PRAGMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004DESYRELTRAZODONE HYDROCHLORIDETABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85061SUPPL 2026-02-18
82660SUPPL 2025-06-25
56052SUPPL2018-10-22
56017SUPPL2018-10-19
56016SUPPL2018-10-19
48907SUPPL2017-07-05
48893SUPPL2017-07-03
48892SUPPL2017-07-03
14946SUPPL2014-07-21
23541ORIG2007-05-09
33456SUPPL2005-01-13
874SUPPL2005-01-13
873SUPPL2004-03-19