Skip to Content

Apadaz Approval Status

  • FDA approved: No
  • Brand name: Apadaz
  • Generic name: acetaminophen and benzhydrocodone hydrochloride
  • Previous name: KP201
  • Company: KemPharm, Inc.
  • Treatment for: Pain

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an investigational abuse-deterrent narcotic analgesic combination in development for the short-term management of acute pain.

On June 13, 2016, KemPharm, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Apadaz. A CRL indicates that the application is not ready for approval in its present form.

Development Status and FDA Approval Process for Apadaz

DateArticle
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.

Hide