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This application refers to the following NDAs for general safety and efficacy of ibuprofen Motrin IB NDA 19-012 Advil Liqui-Gels NDA 20-402 and Advil Tablets Caplets and Gel-Caplets NDA 18-989. The sponsor wishes to utilize the Agency s safety and efficacy findings of ibuprofen to the following NDAs Motrin IB NDA 19-012 Advil Liqui-Gels NDA 20402 and Advil Tablets Caplets and Gel-Caplets NDA 18-989. Table 5 Ibuprofen Pharmacokinetic Parameters Mean Standard Deviation Median AUC0-t g h/mL...
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