FDA.reportPublic FDA data

Application 040736

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-332Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvKARE, Inc.ANDACurrent
42291-332Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvKARE, Inc.ANDACurrent
50090-0843Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-0843Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50090-0844Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenA-S Medication SolutionsANDACurrent
50268-401Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-401Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-401Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-402Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-402Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50268-402Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAvPAKANDACurrent
50436-0109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenUnit Dose ServicesANDACurrent
52959-737Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenH.J Harkins Co., IncANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-109Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals of New York LLCANDACurrent
54348-066HYDROCODONE/APAPHYDROCODONE BITARTRATE, ACETAMINOPHENPharmPak, Inc.ANDACurrent
55700-220Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenLake Erie Medical DBA Quality Care Products LLCANDACurrent
61502-913HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENEPM Packaging IncANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDirect_RxANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDirect_RxANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDirect_RxANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDIRECT RXANDACurrent
61919-494HYDROCODONE BITARTRATEHYDROCODONE BITARTRATEDirect_RxANDACurrent
63187-112Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63187-112Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenProficient Rx LPANDACurrent
63629-5422Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5422Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-5422Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7821Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63629-7821Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenBryant Ranch PrepackANDACurrent
63739-326Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenMcKesson CorporationANDACurrent
67296-0299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-0299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-0299Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
68084-895Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmerican Health PackagingANDACurrent
68788-9250Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9250Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76298ORIG 2023-11-03