FDA.reportPublic FDA data

Application 201194

Type
NDA
Sponsor
VISTAPHARM

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-401Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
66689-403Oxycodone HydrochlorideOxycodone HydrochlorideVistaPharm, Inc.NDACurrent
67296-1595Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.NDACurrent
67296-1595Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.NDACurrent
67296-1595Oxycodone HydrochlorideOxycodone HydrochlorideRedPharm Drug, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84674SUPPL 2026-01-06
84570SUPPL 2025-12-29
80082SUPPL 2024-11-04
78213SUPPL 2024-04-23
78212SUPPL 2024-04-23
78189SUPPL 2024-04-22
77072SUPPL 2023-12-19
76946SUPPL 2023-12-18
76242ORIG 2023-11-03
68175SUPPL2021-07-23
68174SUPPL2021-07-23
68157SUPPL2021-07-22
66635SUPPL2021-03-08
66634SUPPL2021-03-08
66573SUPPL2021-03-08
60451SUPPL2019-10-09
60399SUPPL2019-10-08
60398SUPPL2019-10-08
55704SUPPL2018-10-01
55703SUPPL2018-10-01
55582SUPPL2018-09-24
55581SUPPL2018-09-24
46419SUPPL2016-12-21
46309SUPPL2016-12-20
44832ORIG2012-08-29
43359ORIG2012-08-29
40051ORIG2012-01-23
32086ORIG2012-01-17