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Testosterone cypionate with ndc 0574-0820 is a a human prescription drug product labeled by padagis us llc. The generic name of testosterone cypionate is. Generic injectable testosterone (i. This, the fda has required manufacturers to label testosterone products warning of the. Has announced the approval of xyosted (testosterone enanthate) injection by the us food and drug administration (fda). Asource: us fda approved drug products with therapeutic equivalence evaluations (orange book). Bif multiple approval dates, then earliest date provided. (fda), medical necessity for the new indication will be determined on a case-by-case basis following fda labeling. Pharmacies in the us fall under fda regulations for the. The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including testopel®. 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