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Benzhydrocodone/paracetamol - KemPharm

Drug Profile

Benzhydrocodone/paracetamol - KemPharm

Alternative Names: Acetaminophen/benzhydrocodone; Acetaminophen/KP-201; AG-APADAZ; 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: 14 Jan 2019

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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.

  • New Molecular Entity No

Highest Development Phases

  • Registered Acute pain

Most Recent Events

  • 31 Oct 2019 KemPharm and KVK-Tech intend to launch APADAZ its authorized generic in the US in November 2019
  • 07 Jan 2019 The US FDA approves Supplemental New Drug Application for Benzhydrocodone/paracetamol for two new doses
  • 30 Oct 2018 KemPharm enters into a collaboration and licensing agreement with KVK Tech for the commercialisation of benzhydrocodone/paracetamol in USA
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