Application Nr Approved Date Route Status External Links
ANDA200491 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Tramadol Hydrochloride Extended-Release Tablets Are Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse, With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Extended-Release Opioid Formulations [See Warnings ], Reserve Tramadol Hydrochloride Extended-Release Tablets For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Immediate-Release Opioids], Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. Tramadol Hydrochloride Extended-Release Tablets Are Not Indicated As An As-Needed (Prn) Analgesic.

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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