Promethazine/hydrocodone/paracetamol - Charleston Laboratories

Drug Profile

Promethazine/hydrocodone/paracetamol - Charleston Laboratories

Alternative Names: CL-108; Hydrocodone/paracetamol/promethazine; Paracetamol/promethazine/hydrocodone

Latest Information Update: 01 Sep 2017

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At a glance

  • Originator Charleston Laboratories
  • Class Acetanilides; Antiemetics; Antipyretics; Morphinans; Non-opioid analgesics; Opioid analgesics; Propylamines
  • Mechanism of Action Histamine H1 receptor antagonists; Muscarinic receptor antagonists; Opioid receptor agonists; Prostaglandin receptor antagonists; Serotonin 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

Highest Development Phases

  • Preregistration Acute pain; Nausea and vomiting

Most Recent Events

  • 31 Aug 2017 Charleston Laboratories reacquires rights to promethazine/hydrocodone/paracetamol from Daiichi Sankyo Company for Acute pain, Nausea and vomiting, following termination of development and marketing agreement
  • 31 Aug 2017 Charleston Laboratories intends to resubmit NDA for promethazine/hydrocodone/paracetamol for Acute pain, Nausea and vomiting
  • 03 Feb 2017 Charleston Laboratories and Daiichi Sankyo receive complete response letter from the FDA for promethazine/hydrocodone/paracetamol in Acute pain and nausea and Vomiting (Prevention)
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