Application 213562

Type
ANDA
Sponsor
AMNEAL EU LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL0.25MGNoNo
002BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL0.5MGNoNo
003BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL1MGNoNo
004BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL2MGNoNo
005BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL3MGNoNo
006BREXPIPRAZOLEBREXPIPRAZOLETABLET;ORAL4MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69660ORIG2021-12-20