Application 084051

Type
ANDA
Sponsor
SHIRE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSTATDEXTROAMPHETAMINE SULFATETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002DEXTROSTATDEXTROAMPHETAMINE SULFATETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44405ORIG2011-12-20