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Rexista Approval Status

FDA Approved: No
Brand name: Rexista
Generic name: oxycodone hydrochloride
Dosage form: Extended-Release Tablets
Company: Intellipharmaceutics International Inc.
Treatment for: Pain

Rexista (oxycodone hydrochloride extended release) is an abuse and alcohol-deterrent controlled-release formulation of oxycodone hydrochloride in development for the relief of moderate to severe pain.

Development Status and FDA Approval Process for Rexista

DateArticle
Mar  4, 2019Intellipharmaceutics Announces Resubmission of New Drug Application to the U.S. FDA for its Oxycodone ER
Sep 25, 2017Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista NDA
Feb  2, 2017Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista (oxycodone hydrochloride extended release) Abuse Deterrent Opioid Analgesic
Nov 25, 2016Intellipharmaceutics Submits NDA for Rexista (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
May 21, 2015Intellipharmaceutics Intends to Accelerate its Rexista Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA

Further information

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