FDA Approval Activities for this Drug…

Prelay (Troglitazone) Tablets Sankyo U.S.A. NDA 20-719/S012 Rezulin (troglitazone) Tablets, 200mg, 300mg, & 400mg, only Parke-Davis NDA 20-720/ S-012 /S-014 6/16/99 6/17/99 6/17/99 7/3/00 Rezulin Indication: Supplement 012 provides for the use of Rezulin in combination with metformin and sulfonylures in patients with type 2 diabetes.

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