Loratadine and montelukast Approval Status

  • FDA approved: No
  • Generic name: loratadine and montelukast
  • Company: Schering-Plough/Merck Pharmaceuticals
  • Treatment for: Hay Fever

This medicine is a single tablet that contains the active ingredients of Claritin (loratadine) and Singulair (montelukast sodium), both of which are indicated for the relief of symptoms of allergic rhinitis.

FDA Approval Status for loratadine and montelukast

DateArticle
Jun 27, 2008Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture
Apr 28, 2008Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast
Aug 28, 2007Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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