FDA.reportPublic FDA data

Application 206869

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL300MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent
65162-675Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76053ORIG 2023-11-02
48837ORIG2017-06-27