FDA.reportPublic FDA data

Application 204094

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLESOLUTION;ORAL1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0404aripiprazolearipiprazoleApotex Corp.ANDACurrent
60505-0404aripiprazolearipiprazoleApotex Corp.ANDACurrent
60505-0404aripiprazolearipiprazoleApotex Corp.ANDACurrent
60505-0404aripiprazolearipiprazoleApotex Corp.ANDACurrent
60505-0404aripiprazolearipiprazoleApotex Corp.ANDACurrent