FDA.reportPublic FDA data

Application 202991

Type
ANDA
Sponsor
RHODES PHARMS

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
42858-201Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-201Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-201Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-202Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-202Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-202Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-203Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-203Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
42858-203Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRhodes Pharmaceuticals L.P.ANDACurrent
50090-4065Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4065Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4066Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4066Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-4071Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
63629-2468Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2468Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2468Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2469Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2469Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2469Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2471Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2471Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-2471Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8499Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-8499Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
67296-1333Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1333Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1333Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1334Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1334Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1334Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1335Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1335Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1335Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
71335-1417Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1417Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1418Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1419Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1419Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1444Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1444Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1444Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1444Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1444Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1470Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1557Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1557Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1557Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-1811Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
76420-133Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAsclemed USA, Inc.ANDACurrent
76420-133Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAsclemed USA, Inc.ANDACurrent
76420-215Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAsclemed USA, Inc.ANDACurrent
76420-257Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76160ORIG 2023-11-03