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Vantrela ER FDA Approval History

FDA Approved: Yes (Discontinued) (First approved January 17, 2017)
Brand name: Vantrela ER
Generic name: hydrocodone bitartrate
Dosage form: Extended-Release Tablets
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Pain

Marketing Status: Discontinued

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Development timeline for Vantrela ER

DateArticle
Jan 18, 2017Approval Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology
Jun  7, 2016Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Further information

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