FDA.reportPublic FDA data

Application 005213

Type
NDA
Sponsor
GENUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYCODANHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATETABLET;ORAL1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002HYCODANHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATESYRUP;ORAL1.5MG/5ML;5MG/5MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64950-205HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-205HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-205HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-206Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDA AUTHORIZED GENERICCurrent
64950-342HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-342HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-342HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-342HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-342HycodanHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDACurrent
64950-371Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideGenus Lifesciences Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84714SUPPL 2026-01-07
84527SUPPL 2025-12-23
76907SUPPL 2023-12-18
76906SUPPL 2023-12-18
68866SUPPL2021-10-04
68865SUPPL2021-10-04
54850SUPPL2018-07-06
54787SUPPL2018-07-06
54750SUPPL2018-07-05
46896SUPPL2017-01-19
46872SUPPL2017-01-13
40643SUPPL2013-02-27
32926SUPPL2009-02-04
14SUPPL2009-01-30