Hydromorphone Oral Solution

Brand(s)
Dilaudid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Purdue Pharma Lp (2013-06-17)
Oldest Current Product
1956-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SOLUTION\HYDROMORPHONE
FDAOB
ORAL\SOLUTION\HYDROMORPHONE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\HYDROMORPHONE HYDROCHLORIDE
ORAL\SOLUTION\HYDROMORPHONE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\HYDROMORPHONE
ORAL\SOLUTION\HYDROMORPHONE

product(s) by strength(s)

hydromorphone hydrochloride 1 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110451DilaudidNDAPurdue Pharma Lp1956-01-01HYDROMORPHONE HYDROCHLORIDEORALLIQUIDNDA0198913afae8b9-bb24-447a-bc7f-041c8326a438

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540386ANDARoxane Laboratories, Inc2012-03-01HYDROMORPHONE HYDROCHLORIDEORALSOLUTIONANDA074653cc574063-6ede-4da7-82c4-7450c92b229b
2428580304NDA AUTHORIZED GENERICRhodes Pharmaceuticals L.P.2012-07-20HYDROMORPHONE HYDROCHLORIDEORALSOLUTIONNDA01989137565441-0d95-4743-a695-d7b3326f58a1

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA074653HYDROMORPHONE HYDROCHLORIDEROXANE LABORATORIES INC1998-07-29ANDA074653_001
2NDA019891DILAUDIDPURDUE PHARMACEUTICAL PRODUCTS LP1992-12-07p6589960, SUBSTANCENDA019891_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074653_001RXHYDROMORPHONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA1998-07-29HYDROMORPHONE HYDROCHLORIDE
2NDA019891_001RXHYDROMORPHONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONTrueAA1992-12-07DILAUDID

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6589960 (view patent)2020-11-09NDA019891, NDA019034, NDA019892, NDA021044Hydromorphone Oral Tablet
Hydromorphone Injectable Solution
Hydromorphone Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
137565441-0d95-4743-a695-d7b3326f58a1 (view SPL)Hydromorphone Hydrochloride Oral Solution, USP Hydromorphone Hydrochloride Tablets, USP Rx OnlyprescriptionHuman PrescriptionRhodes Pharmaceuticals L.P.MANUFACTURE2014-04-0810428580304, 428580301, 428580302, 428580303Hydromorphone Oral Tablet
23afae8b9-bb24-447a-bc7f-041c8326a438 (view SPL)Dilaudid (hydromorphone hydrochloride) Oral LiquidDilaudid (hydromorphone hydrochloride) TabletsprescriptionHuman PrescriptionPurdue Pharma LpMANUFACTURE2013-06-174590110451, 590110452, 590110454, 590110458Hydromorphone Oral Tablet
3cc574063-6ede-4da7-82c4-7450c92b229b (view SPL)HYDROMORPHONE HYDROCHLORIDE Tablets, USP HYDROMORPHONE HYDROCHLORIDE Oral Solution, USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-08-109000540386, 000540264, 000540265Hydromorphone Oral Tablet

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII