Application 216743

Type
NDA
Sponsor
ZYDUS LIFESCIENCES

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZITUVIMETMETFORMIN HYDROCHLORIDE; SITAGLIPTINTABLET;ORAL500MG;50MGYesNo
002ZITUVIMETMETFORMIN HYDROCHLORIDE; SITAGLIPTINTABLET;ORAL1GM;50MGYesYes

Documents

DocumentSubmission typeDate
85776SUPPL 2026-04-28
85767SUPPL 2026-04-27
78973ORIG 2024-07-03
76382ORIG 2023-11-06
76381ORIG 2023-11-06
76373ORIG 2023-11-06