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36Ultram Generics Will Reference 50 mg, But Not 25 Mg, Titration Schedule

Executive Summary

FDA is approving Ultram (tramadol) generics with labeling that includes the 50 mg titration regimen, but not the protected 25 mg titration schedule

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Ultram Generic Labeling Should Require 25 Mg Titration Regimen, J&J Says

Johnson & Johnson is willing to waive its exclusivity for the protected 25 mg titration schedule for Ultram (tramadol) if FDA makes a determination that that schedule is superior to the 50 mg titration regimen

Ultram Generic Labeling Should Require 25 Mg Titration Regimen, J&J Says

Johnson & Johnson is willing to waive its exclusivity for the protected 25 mg titration schedule for Ultram (tramadol) if FDA makes a determination that that schedule is superior to the 50 mg titration regimen

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