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: 07 Feb 2017

Price : $50

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.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Acute pain; Nausea and vomiting

Most Recent Events

  • 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)
  • 26 Sep 2016 Efficacy data from a phase III trial in Pain released by Charleston Laboratories
  • 13 Jun 2016 Planned Prescription Drug User Fee Act (PDUFA) date for Acute pain in USA (PO) is 2017-01-31
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