Application 211566

Type
NDA
Sponsor
ZYDUS WORLDWIDE DMCC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SITAGLIPTINSITAGLIPTINTABLET; ORAL25MGNoNo
002ZITUVIOSITAGLIPTINTABLET;ORAL50MGYesNo
003ZITUVIOSITAGLIPTINTABLET;ORAL100MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79841ORIG 2024-10-09
75851ORIG 2023-10-19
75850ORIG 2023-10-19
68553ORIG2021-09-08