Application Nr Approved Date Route Status External Links
NDA019892 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dilaudid Oral Solution And Dilaudid Tablets Are Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Dilaudid Oral Solution And Dilaudid Tablets Contain Hydromorphone, An Opioid Agonist, And Are Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. ( 1 ) Limitations Of Use ( 1 ) Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Dilaudid Oral Solution Or Dilaudid Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [See Warnings And Precautions (5.2) ] , Reserve Dilaudid Oral Solution And Dilaudid Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE ZINC402954

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