FDA.reportPublic FDA data

Application 200535

Type
NDA
Sponsor
GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL100MG/5MLYesYes
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESOLUTION;ORAL5MG/5MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
48433-347Oxycodone HydrochlorideOxycodone HydrochlorideSafecor Health, LLCNDA AUTHORIZED GENERICCurrent
48433-347Oxycodone HydrochlorideOxycodone HydrochlorideSafecor Health, LLCNDA AUTHORIZED GENERICCurrent
48433-347Oxycodone HydrochlorideOxycodone HydrochlorideSafecor Health, LLCNDA AUTHORIZED GENERICCurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-353Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
64950-354Oxycodone HydrochlorideOxycodone HydrochlorideGenus Lifesciences Inc.NDACurrent
68462-347Oxycodone HydrochlorideOxycodone HydrochlorideGlenmark Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84639SUPPL 2026-01-05
84569SUPPL 2025-12-29
80081SUPPL 2024-11-04
78220SUPPL 2024-04-23
78219SUPPL 2024-04-23
78188SUPPL 2024-04-22
77071SUPPL 2023-12-19
76945SUPPL 2023-12-18
76241ORIG 2023-11-03
68173SUPPL2021-07-23
68172SUPPL2021-07-23
68160SUPPL2021-07-22
66572SUPPL2021-03-08
66528SUPPL2021-03-05
66526SUPPL2021-03-05
60450SUPPL2019-10-09
60397SUPPL2019-10-08
60396SUPPL2019-10-08
55710SUPPL2018-10-01
55709SUPPL2018-10-01
55586SUPPL2018-09-24
55585SUPPL2018-09-24
46414SUPPL2016-12-21
46326SUPPL2016-12-20
40027SUPPL2014-06-23
32034SUPPL2013-09-05
32033SUPPL2013-09-05
40026SUPPL2013-08-27
18964SUPPL2013-08-27
9828SUPPL2012-01-30
44823ORIG2011-02-24
43347ORIG2011-02-24
40025ORIG2010-10-29
32032ORIG2010-10-25
43941ORIG2010-10-21