FDA.reportPublic FDA data

Application 200534

Type
NDA
Sponsor
GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDECAPSULE;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-3803Oxycodone HydrochlorideOxycodone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
64950-901Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-901Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-901Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-901Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
68462-204Oxycodone HydrochlorideOxycodone HydrochlorideGlenmark Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84638SUPPL 2026-01-05
84568SUPPL 2025-12-29
80080SUPPL 2024-11-04
78217SUPPL 2024-04-23
78216SUPPL 2024-04-23
78187SUPPL 2024-04-22
77052SUPPL 2023-12-19
76944SUPPL 2023-12-18
76240ORIG 2023-11-03
68171SUPPL2021-07-23
68170SUPPL2021-07-23
68159SUPPL2021-07-22
66629SUPPL2021-03-08
66628SUPPL2021-03-08
66571SUPPL2021-03-08
60449SUPPL2019-10-09
60395SUPPL2019-10-08
60394SUPPL2019-10-08
55999SUPPL2018-10-17
55998SUPPL2018-10-17
55728SUPPL2018-10-01
55727SUPPL2018-10-01
46412SUPPL2016-12-21
46327SUPPL2016-12-20
44822ORIG2011-02-24
22832ORIG2011-02-24
32031ORIG2010-10-26
18963ORIG2010-10-21