Application Nr Approved Date Route Status External Links
NDA019034 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dilaudid Injection Is Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternate Treatments Are Inadequate. Dilaudid Injection Is An Opioid Agonist Indicated For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternate Treatments Are Inadequate. ( 1 ) Limitations Of Use: Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Dilaudid Injection 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 ( 5.1 )] , Reserve Dilaudid Injection 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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