FDA.reportPublic FDA data

Application 076642

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL7.5MG;200MGNoYes
002HYDROCODONE BITARTRATE AND IBUPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL5MG;200MGNoNo
003REPREXAINHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL2.5MG;200MGNoNo
004REPREXAINHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL10MG;200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-268Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenRebel Distributors CorpANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-116Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-117Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-145Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-146Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
63629-5437Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenBryant Ranch PrepackANDACurrent
63629-5437Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenBryant Ranch PrepackANDACurrent
63739-557Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenMcKesson Packaging Services a business unit of McKesson CorporationANDACurrent
68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmerican Health PackagingANDACurrent
68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmerican Health PackagingANDACurrent
68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmerican Health PackagingANDACurrent
68084-841Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenAmerican Health PackagingANDACurrent
71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenBryant Ranch PrepackANDACurrent
71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenBryant Ranch PrepackANDACurrent
71335-0104Hydrocodone Bitartrate and IbuprofenHydrocodone Bitartrate and IbuprofenBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76308ORIG 2023-11-02
43092ORIG2011-01-07
31149SUPPL2007-10-22
31148SUPPL2007-10-22
8940SUPPL2007-10-22
8939SUPPL2007-10-22