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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. In June 2008, Schering-Plough and Merck announced the withdrawal of the NDA for the loratadine/montelukast combination tablet.

FDA Approval Status for loratadine and montelukast

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

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