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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

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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