Application Nr Approved Date Route Status External Links
NDA200535 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Oxycodone Hydrochloride Oral Solution 100 Mg/5 Ml ( 20 Mg/ml ) Is An Opioid Analgesic Indicated For The Management Of Moderate To Severe Acute And Chronic Pain In Opioid-Tolerant Patients. Oxycodone Hydrochloride Oral Solution 100 Mg/5 Ml (20 Mg/ml) May Cause Fatal Respiratory Depression When Administered To Patients Not Previously Exposed To Opioids. Patients Considered To Be Opioid Tolerant Are Those Who Are Taking At Least 30 Mg Of Oral Oxycodone Per Day, Or At Least 60 Mg Oral Morphine Per Day, Or At Least 12 Mg Hydromorphone Per Day, Or An Equianalgesic Dose Of Another Opioid, For A Week Or Longer. Oxycodone Hydrochloride 20 Mg Per Ml Solution Is An Opioid Agonist Indicated For The Management Of Moderate To Severe Acute And Chronic Pain In Opioid-Tolerant Patients. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE ZINC403533

Comments