FDA.reportPublic FDA data

Application 019892

Type
NDA
Sponsor
RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILAUDIDHYDROMORPHONE HYDROCHLORIDETABLET;ORAL8MGYesYes
002DILAUDIDHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGYesNo
003DILAUDIDHYDROMORPHONE HYDROCHLORIDETABLET;ORAL2MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-122Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-122Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-122Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-122Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-234Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-234Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-234Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-234Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-301Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-301Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-301Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-301Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-302Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-302Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-302Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-302Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-303Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-303Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-303Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-303Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-338Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-338Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-338Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-338Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
55154-1610Dilaudidhydromorphone hydrochlorideCardinal HealthNDACurrent
59011-452DILAUDIDHYDROMORPHONE HYDROCHLORIDEPurdue Pharma LPNDACurrent
59011-454DILAUDIDHYDROMORPHONE HYDROCHLORIDEPurdue Pharma LPNDACurrent
59011-458DILAUDIDHYDROMORPHONE HYDROCHLORIDEPurdue Pharma LPNDACurrent
63629-3798Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3798Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-4284Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-4284Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-4284Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-4284Hydromorphone HydrochlorideHydromorphone HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
65084-440DILAUDIDHYDROMORPHONE HYDROCHLORIDEMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84683SUPPL 2026-01-06
84591SUPPL 2025-12-29
80090SUPPL 2024-11-04
76995SUPPL 2023-12-19
76896SUPPL 2023-12-18
76895SUPPL 2023-12-18
76228ORIG 2023-11-03
66518SUPPL2021-03-05
66517SUPPL2021-03-05
66508SUPPL2021-03-05
60355SUPPL2019-10-08
60316SUPPL2019-10-08
60313SUPPL2019-10-08
55659SUPPL2018-09-28
55658SUPPL2018-09-28
55605SUPPL2018-09-24
55604SUPPL2018-09-24
46393SUPPL2016-12-21
46240SUPPL2016-12-20
11822SUPPL2007-11-19
1780SUPPL2007-11-19
19799SUPPL2006-06-12
11821SUPPL2006-06-12
1779SUPPL2004-06-02