Application Nr Approved Date Route Status External Links
ANDA211825 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tramadol Hydrochloride Tablets Are Indicated In Adults For The Management Of Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. 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 Tramadol Hydrochloride Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics]: Have Not Been Tolerated Or Are Not Expected To Be Tolerated. Have Not Provided Adequate Analgesia Or Are Not Expected To Provide Adequate Analgesia. Tramadol Hydrochloride Is An Opioid Agonist Indicated In Adults 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 ( 5.1 ), Reserve Tramadol Hydrochloride Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics]: 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. Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE ZINC853

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