FDA.reportPublic FDA data

Application 200343

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATESOLUTION;ORAL325MG/15ML;7.5MG/15MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64950-340Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenGenus Lifesciences Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-004Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-005Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent
66689-023Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenVistaPharm, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76189ORIG 2023-11-03