FDA.reportPublic FDA data

Application 203864

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-114Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-114Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-114Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-114Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-115Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-115Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-115Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-115Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-116Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-116Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-116Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent
42806-116Oxycodone and AcetaminophenOxycodone and AcetaminophenEpic Pharma, LLCANDACurrent