FDA.reportPublic FDA data

Application 202935

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0254-2034Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2034Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2034Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2035Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
0254-2036Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPar Pharmaceutical, Inc.ANDACurrent
71335-1248Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1248Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76137ORIG 2023-11-03