FDA.reportPublic FDA data

Application 040894

Type
ANDA
Sponsor
GENUS

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
17856-0640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, AcetaminophenAtlantic Biologicals CorpsANDACurrent
64376-640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, AcetaminophenPar PharmaceuticalANDACurrent
64376-640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, AcetaminophenPar PharmaceuticalANDACurrent
64950-343Hydrocodone Bitartrate and Acetaminophenhydrocodone bitartrate and acetaminophenGenus Lifesciences Inc.ANDACurrent
64950-343Hydrocodone Bitartrate and Acetaminophenhydrocodone bitartrate and acetaminophenGenus Lifesciences Inc.ANDACurrent
68094-714Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPrecision Dose Inc.ANDACurrent
68094-714Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPrecision Dose Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76153ORIG 2023-11-03