FDA.reportPublic FDA data

Application 214278

Type
NDA
Sponsor
Dexcel Pharma Technologies Ltd.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESOMEPRAZOLEESOMEPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL20MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71087SUPPL2022-05-17
71058SUPPL2022-05-12
68565SUPPL2021-09-09
66206ORIG2021-02-12
64966ORIG2020-10-21