FDA.reportPublic FDA data

Application 210211

Type
ANDA
Sponsor
WES PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;5MGNoNo
002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;7.5MGNoNo
003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL325MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-396Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-396Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-396Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-407Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-407Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-407Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-407Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
60687-418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
63629-1938Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1938Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1938Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1939Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1939Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1939Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-1940Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8885Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8886Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8887Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
68071-2494Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2629Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2645Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2664Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2664Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2762Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1970Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2116Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-2144Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-019Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-020Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent
71930-021Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenEywa Pharma IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76204ORIG 2023-11-03