Oropharyngeal Candidiasis

• FDA approval · 2017-06-08
  FDA Approved: NYSTATIN — Original Application (Zydus Lifesciences Limited)

  FDA approves the original application for Nystatin from Zydus Lifesciences Limited.

• FDA approval · 2015-03-19
  FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Fluconazole from Hikma Pharmaceuticals USA Inc., updating the regulatory approval of this pr…

• FDA approval · 2015-03-14
  FDA Approved: FLUCONAZOLE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for fluconazole from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2015-02-27
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for fluconazole from Rising Pharma Holdings, Inc. for a generic fluconazole product.

• FDA approval · 2014-03-24
  FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, an intravenous formulation of fluconazole.

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• FDA approval · 2013-03-05
  FDA Approved: ORAVIG — Supplemental Application (Galt Pharmaceuticals, LLC)

  FDA approved a supplemental application for ORAVIG (miconazole) submitted by Galt Pharmaceuticals, LLC.

• FDA approval · 2012-03-14
  FDA Approved: FLUCONAZOLE — Supplemental Application (Hospira, Inc)

  The FDA approved a supplemental application for fluconazole submitted by Hospira, Inc., authorizing changes to the product under the ANDA.

• FDA approval · 2012-01-30
  FDA Approved: FLUCONAZOLE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s generic fluconazole under Original Application (ANDA 078698). The approval covers multiple fun…

• FDA approval · 2012-01-25
  FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fluconazole submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2011-10-13
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for fluconazole by Rising Pharma Holdings, Inc., authorizing an updated generic product under the AN…

• FDA approval · 2011-04-08
  FDA Approved: ORAVIG — Supplemental Application (Galt Pharmaceuticals, LLC)

  The FDA approved a supplemental application for ORAVIG (miconazole) from Galt Pharmaceuticals, LLC. This action updates/expands the product'…

• FDA approval · 2011-03-07
  FDA Approved: FLUCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)

  ANI Pharmaceuticals received FDA approval for an original generic application of fluconazole.

• FDA approval · 2010-04-16
  FDA Approved: ORAVIG — Original Application (Galt Pharmaceuticals, LLC)

  FDA approves ORAVIG (miconazole) under an original NDA from Galt Pharmaceuticals, LLC for the treatment of oropharyngeal candidiasis.

• FDA approval · 2009-09-18
  FDA Approved: FLUCONAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for fluconazole from Rising Pharma Holdings, Inc., enabling the generic antifungal to enter the market…