FDA.reportPublic FDA data

Application 040746

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-144Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenApotheca, Inc.ANDACurrent
21695-272Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRebel Distributors Corp.ANDACurrent
42291-333Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvKARE, Inc.ANDACurrent
42291-334Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvKARE, Inc.ANDACurrent
42291-334Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvKARE, Inc.ANDACurrent
50268-400Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-400Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-110Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
55700-224Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61502-908HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENEPM Packaging IncANDACurrent
61919-118HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-118HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-118HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-118HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
63187-120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-120Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63629-2947Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5434Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5434Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5434Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5434Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7823Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-115Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
67296-1377Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1377Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1377Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68387-235Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenKeltman Pharmaceuticals Inc.ANDACurrent
68788-9297Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent
71335-0466Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0466Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
71335-0466Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76441ORIG 2023-11-07