Application 220313

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID;ORAL1.1GM/MLNoNo
002GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID1.1G/1MLNoNo
003GLYCEROL PHENYLBUTYRATEGLYCEROL PHENYLBUTYRATELIQUID450MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84995ORIG 2026-02-11