Benzhydrocodone/paracetamol - KemPharm

Drug Profile

Benzhydrocodone/paracetamol - KemPharm

Alternative Names: Acetaminophen/benzhydrocodone; Acetaminophen/KP-201; Apadaz; APAP/KP-201; Benzhydrocodone and acetaminophen; Benzhydrocodone/acetaminophen; KP-201/acetaminophen; KP-201/APAP; KP201/IR; Paracetamol/benzhydrocodone; Paracetamol/KP-201

Latest Information Update: 26 Feb 2018

Price : *
* Final gross price and currency may vary according to local VAT and billing address.
* Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase. A link to download a PDF version of the drug profile will be included in your email receipt. Adis is an information provider. We do not sell or distribute the pharmaceutical compounds written about in this database.

At a glance

  • Originator KemPharm
  • Class Acetanilides; Antipyretics; Benzoates; Epoxy compounds; Morphinans; Non-opioid analgesics; Opioid analgesics; Opioid peptides; Small molecules
  • Mechanism of Action Opioid receptor agonists; Prostaglandin receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Registered Acute pain

Most Recent Events

  • 23 Feb 2018 Registered for Acute pain in USA (PO)
  • 23 Feb 2018 Benzhydrocodone/paracetamol has a boxed warning for addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; hepatotoxicity; and risks from concomitant use with benzodiazepines or other CNS depressants
  • 12 Sep 2017 FDA accepts amended NDA and assigns PDUFA action date of 23/02/2018 for benzhydrocodone/paracetamol for Acute pain
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top