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Zelapar Approval History

  • FDA approved: Yes (First approved June 14th, 2006)
  • Brand name: Zelapar
  • Generic name: selegiline hydrochloride
  • Dosage form: Orally Disintegrating Tablets
  • Company: Valeant Pharmaceuticals International
  • Treatment for: Parkinson's Disease

Zelapar (selegiline) is an an irreversible inhibitor of monoamine oxidase (MAO) indicated as an adjunct in the management of patients with Parkinson’s disease.

Development History and FDA Approval Process for Zelapar

Jun 14, 2006Approval Zelapar Valeant Pharmaceuticals International - Treatment for Parkinson’s Disease
Oct  4, 2005Valeant Pharmaceuticals Receives Approvable Letter from FDA Regarding Zelapar
Jan  5, 2005Valeant Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zelapar

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