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Apadaz Approval History

  • FDA approved: Yes (First approved February 23rd, 2018)
  • Brand name: Apadaz
  • Generic name: acetaminophen and benzhydrocodone hydrochloride
  • Dosage form: Tablets
  • Previous name: KP201
  • Company: KemPharm, Inc.
  • Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

Development History and FDA Approval Process for Apadaz

Feb 23, 2018Approval FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
Jun 13, 2016FDA Issues Complete Response Letter for Apadaz New Drug Application
May  5, 2016Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz
Apr 16, 2013KemPharm Advances KP201 Clinical and Commercial Program with Completion of Tablet Registration Activities
May 24, 2011KemPharm, Inc. Announces Positive Results from Phase 1 Trial of KP201 for Pain

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