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Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for

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Page 1: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 2: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 3: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 4: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 5: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 6: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for
Page 7: Food and Drug Administration · 2009-01-26 · KOWA RESEARCH INSTITUTE, January 26, 2009 INC. Mary Parks, M.D., Director Division of Metabolism and Endocrinology Products Center for

__13_ Page(s) Withheld

__X___ Trade Secret / Confidential (b4)

______ Draft Labeling (b4)

______ Draft Labeling (b5)

______ Deliberative Process (b5)

Withheld Track Number: Administrative-__2___