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Palladone Approval History

FDA Approved: Yes (Discontinued) (First approved September 24, 2004)
Brand name: Palladone
Generic name: hydromorphone hydrochloride
Dosage form: Extended Release Capsules
Company: Purdue Pharma L.P.
Treatment for: Pain

Marketing Status: Discontinued

Palladone (hydromorphone hydrochloride) is an extended release opioid analgesic indicated for the management of moderate to severe pain in patients requiring continuous, around-the-clock analgesia.

Purdue Pharma suspended the sales and marketing of Palladone in July 2005 at the request of the FDA because of the serious and potentially fatal adverse reactions that can occur when Palladone is taken with alcohol.

Development History and FDA Approval Process for Palladone

DateArticle
Sep 24, 2004Approval FDA Approves Palladone (hydromorphone HCl extended-release) Capsules (CII) For The Management Of Persistent, Moderate To Severe Pain

Further information

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