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Xtampza ER FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 2, 2021.

FDA Approved: Yes (First approved April 26, 2016)
Brand name: Xtampza ER
Generic name: oxycodone
Dosage form: Extended-Release Capsules
Company: Collegium Pharmaceutical, Inc.
Treatment for: Chronic Pain

Xtampza ER (oxycodone) is an extended-release, abuse-deterrent, narcotic analgesic for the treatment of chronic pain.

Development timeline for Xtampza ER

Apr 26, 2016Approval Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties
Nov  9, 2015Collegium Announces FDA Tentative Approval for Xtampza ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain
Oct 12, 2015Collegium Provides Update on FDA Review of Xtampza ER, an Abuse-Deterrent Analgesic for the Treatment of Chronic Pain
Sep 11, 2015Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
Aug  7, 2015Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
Feb 12, 2015Collegium Announces FDA Acceptance for Filing of NDA for Abuse-Deterrent Xtampza ER (oxycodone)
Dec 15, 2014Collegium Pharmaceutical Submits NDA for Xtampza ER (oxycodone) Abuse-Deterrent Analgesic

Further information

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