FDA.reportPublic FDA data

Application 040776

Type
ANDA
Sponsor
OUTLOOK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATESOLUTION;ORAL5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13551-701ProCentradextroamphetamine sulfateFSC Laboratories, IncANDACurrent
21724-701Procentradextroamphetamine sulfateIndependence Pharmaceuticals, LLCANDACurrent
21724-701Procentradextroamphetamine sulfateIndependence Pharmaceuticals, LLCANDACurrent
21724-701Procentradextroamphetamine sulfateIndependence Pharmaceuticals, LLCANDACurrent
46672-646dextroamphetamine sulfatedextroamphetamine sulfateMikart, Inc.ANDACurrent
46672-646dextroamphetamine sulfatedextroamphetamine sulfateMikart, LLCANDACurrent
66993-359dextroamphetamine sulfatedextroamphetamine sulfatePrasco LaboratoriesANDACurrent
66993-359dextroamphetamine sulfatedextroamphetamine sulfatePrasco LaboratoriesANDACurrent
66993-359dextroamphetamine sulfatedextroamphetamine sulfatePrasco LaboratoriesANDACurrent
76181-002dextroamphetamine sulfatedextroamphetamine sulfateAvadel Generics, LLCANDACurrent
76181-002dextroamphetamine sulfatedextroamphetamine sulfateAvadel Generics, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42637ORIG2013-01-24
23420ORIG2008-02-28