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CL-108 Approval Status

  • FDA approved: No
  • Brand name: CL-108
  • Generic name: acetaminophen, hydrocodone and promethazine
  • Company: Charleston Laboratories, Inc. and Daiichi Sankyo, Inc.
  • Treatment for: Pain, Nausea/Vomiting

CL-108 is an analgesic and antihistamine fixed-dose combination in development for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

Development Status and FDA Approval Process for CL-108

Jun 13, 2016Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108

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