FDA.reportPublic FDA data

Application 079217

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DRONABINOLDRONABINOLCAPSULE;ORAL2.5MGNoNo
002DRONABINOLDRONABINOLCAPSULE;ORAL5MGNoNo
003DRONABINOLDRONABINOLCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-761DronabinolDronabinolAkornANDACurrent
17478-761DronabinolDronabinolAkorn, Inc.ANDACurrent
17478-761DronabinolDronabinolAkornANDACurrent
17478-761DronabinolDronabinolAkorn, Inc.ANDACurrent
17478-762DronabinolDronabinolAkornANDACurrent
17478-762DronabinolDronabinolAkorn, Inc.ANDACurrent
17478-762DronabinolDronabinolAkornANDACurrent
17478-762DronabinolDronabinolAkorn, Inc.ANDACurrent
17478-763DronabinolDronabinolAkornANDACurrent
17478-763DronabinolDronabinolAkorn, Inc.ANDACurrent
17478-763DronabinolDronabinolAkornANDACurrent
17478-763DronabinolDronabinolAkorn, Inc.ANDACurrent