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Metozolv ODT Approval History

  • FDA approved: Yes (First approved September 4th, 2009)
  • Brand name: Metozolv ODT
  • Generic name: metoclopramide
  • Dosage form: Orally Disintegrating Tablets
  • Company: Salix Pharmaceuticals, Ltd.
  • Treatment for: GERD, Gastroparesis

Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.

Development History and FDA Approval Process for Metozolv ODT

Sep  8, 2009Approval Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD
Feb 27, 2009Salix Announces FDA Complete Response Letter for Metozolv ODT
Nov 18, 2008FDA Extends Metozolv ODT Review Date

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