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05 and that no additional nonclinical studies on HBP Lotion are needed. A right-of-reference to both propionate 0. 05. 2014. The purpose of the meeting was to discuss the planned NDA submission for propionate lotion 0. HBP from the Ointment NDA is adequate to support filing of an NDA for HBP Lotion 0. 05 submitted under Section 505 b 1 and that no additional nonclinical studies are needed Yes the inclusion of the above-listed nonclinical toxicology studies on HBP from the Ointment NDA 19968...
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208183orig1s000 - fda is a form required by the Food and Drug Administration (FDA) for certain drug applications.
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