FDA.reportPublic FDA data

Application 211023

Type
ANDA
Sponsor
WES PHARMA INC

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
60687-417Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-417Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-417Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
63629-1941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1941Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71930-027Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-027Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-027Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76443ORIG 2023-11-07