Application 202827

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL20MGNoNo
002LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL30MGNoNo
003LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL40MGNoNo
004LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL50MGNoNo
005LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL60MGNoNo
006LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL70MGNoNo
007LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATECAPSULE;ORAL10MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81542ORIG 2025-03-24