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Q: Is tramadol FDA-approved? A: Ultram (tramadol) is FDA-approved since it is a medication that requires a prescription. The United States Food and Drug Administration (FDA) monitors the health and welfare of the American public by regulating food, drugs, and medical devices. When something is declared “FDA-Approved” it means that it is valid, safe, and effective. When dealing with medication, extensive clinical trials must be submitted by drug manufacturers to prove that their product is safe and effective. The FDA also inspects laboratories and facilities where the drugs are manufactured. In order for drugs to be available through prescription, it must receive approval by the FDA.
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