FDA.reportPublic FDA data

Application 074458

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEGESTROL ACETATEMEGESTROL ACETATETABLET;ORAL20MGNoNo
002MEGESTROL ACETATEMEGESTROL ACETATETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4603Megestrol AcetateMegestrol AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4604Megestrol AcetateMegestrol AcetateWest-Ward Pharmaceuticals Corp.ANDACurrent
53808-0614Megestrol AcetateMEGESTROL ACETATEState of Florida DOH Central PharmacyANDACurrent