Application Nr Approved Date Route Status External Links
ANDA075964 2002-06-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Tramadol Hydrochloride Tablets Are Indicated For The Management Of Pain In Adults That Is 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), 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 (5 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tramadol Hydrochloride TRAMADOL HYDROCHLORIDE ZINC853

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