FDA.reportPublic FDA data

Application 201278

Type
ANDA
Sponsor
RHODES PHARMS

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
42858-102Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-102Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-102Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-102Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-103Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-103Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-103Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-103Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-104Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-104Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-104Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-104Oxycodone and AcetaminophenOxycodone and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
63187-824Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-824Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63187-824Oxycodone and AcetaminophenOxycodone and AcetaminophenProficient Rx LPANDACurrent
63629-8876Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8876Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8879Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8879Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
63629-9501Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1420Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1472Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1472Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1472Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1473Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1473Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1473Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1492Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1492Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1909Oxycodone and AcetaminophenOxycodone and AcetaminophenBryant Ranch PrepackANDACurrent
72189-375Oxycodone/APAPOxycodone/APAPDirect_RxANDACurrent
72189-375Oxycodone/APAPOxycodone/APAPDirect_RxANDACurrent
72189-397PercocetOxycodone/APAPDirect_RxANDACurrent
72189-398PercocetOxycodone/APAPDirect_RxANDACurrent
72189-398PercocetOxycodone/APAPDirect_RxANDACurrent
76420-136Oxycodone and AcetaminophenOxycodone and AcetaminophenAsclemed USA, Inc.ANDACurrent
76420-209Oxycodone and AcetaminophenOxycodone and AcetaminophenAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76159ORIG 2023-11-03
32091ORIG2014-09-03