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Zelapar FDA Approval History

FDA Approved: Yes (First approved June 14, 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 timeline 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

Further information

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