FDA.reportPublic FDA data

Application 019891

Type
NDA
Sponsor
RHODES PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-304Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-304Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-304Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-304Hydromorphone HydrochlorideHydromorphone HydrochlorideRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-416Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-416Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-416Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
42858-416Dilaudidhydromorphone hydrochlorideRhodes Pharmaceuticals L.P.NDACurrent
59011-451DILAUDIDHYDROMORPHONE HYDROCHLORIDEPurdue Pharma LPNDACurrent
60687-566Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84682SUPPL 2026-01-06
84590SUPPL 2025-12-29
80089SUPPL 2024-11-04
76994SUPPL 2023-12-19
76893SUPPL 2023-12-18
76892SUPPL 2023-12-18
76227ORIG 2023-11-03
66516SUPPL2021-03-05
66515SUPPL2021-03-05
66507SUPPL2021-03-05
60353SUPPL2019-10-08
60315SUPPL2019-10-08
60314SUPPL2019-10-08
55657SUPPL2018-09-28
55656SUPPL2018-09-28
55603SUPPL2018-09-24
55602SUPPL2018-09-24
46392SUPPL2016-12-21
46239SUPPL2016-12-20
19798SUPPL2006-06-12
11820SUPPL2006-06-12