FDA.reportPublic FDA data

Application 201447

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2981Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2981Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2981Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2982Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2982Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2982Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2983Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2983Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
0228-2983Oxycodone and AcetaminophenOxycodone and AcetaminophenActavis Pharma, Inc.ANDACurrent
50436-2982Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
50436-2982Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
50436-2983Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
50436-2983Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
50436-3913Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent
50436-3913Oxycodone and AcetaminophenOxycodone and AcetaminophenUnit Dose ServicesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76325ORIG 2023-11-03