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Oravig Approval History

  • FDA approved: Yes (First approved April 16th, 2010)
  • Brand name: Oravig
  • Generic name: miconazole
  • Previous name: Loramyc
  • Company: BioAlliance Pharma SA
  • Treatment for: Oral Thrush

Oravig (miconazole) is a mucoadhesive buccal azole antifungal therapy indicated for the local treatment of oropharyngeal candidiasis in adults.

FDA Approval History for Oravig

DateArticle
Apr 16, 2010Approval FDA Approves Oravig (miconazole) Buccal Tablets for Treatment of Oropharyngeal Candidiasis
Aug 19, 2009BioAlliance Pharma: FDA Accepts Drug Application for Miconazole Lauriad (Loramyc) to Treat Oropharyngeal Candidiasis
Jun 16, 2009Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws
May  7, 2009Bioalliance Pharma to Resubmit Loramyc NDA in the Second Quarter of 2009
Apr  9, 2009Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive 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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