Esophageal Candidiasis

• FDA approval · 2015-02-03
  FDA Approved: VFEND — Supplemental Application (Roerig)

  FDA approved a supplemental application for VFEND (voriconazole) from Roerig, resulting in an update/expansion of the product's labeling.

• FDA approval · 2014-10-23
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for CANCIDAS (caspofungin acetate) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2014-04-07
  FDA Approved: VFEND — Supplemental Application (Roerig)

  FDA approved a supplemental application for VFEND (voriconazole) submitted by Roerig.

• FDA approval · 2014-03-28
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA's supplemental application for ERAXIS (anidulafungin) submitted by Roerig is noted as a supplemental approval action. The entry shows th…

• 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 · 2013-12-18
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC to update its labeling.

• FDA approval · 2013-01-08
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for CANCIDAS (caspofungin acetate) from Merck Sharp & Dohme LLC, authorizing changes to the drug's l…

• FDA approval · 2012-05-30
  FDA Approved: VORICONAZOLE — Original Application (Sandoz Inc)

  The FDA approved Sandoz Inc's original application for a generic Voriconazole, enabling its marketing in the United States for the same indi…

• 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 · 2011-06-08
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYCAMINE (micafungin sodium) from Astellas Pharma US, Inc., updating its labeling with indicatio…

• 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 · 2010-11-21
  FDA Approved: VFEND — Supplemental Application (Roerig)

  FDA approved a supplemental application for VFEND (voriconazole) submitted by Roerig. The supplement updates the labeling for the antifungal…

• 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…

• FDA approval · 2009-07-30
  FDA Approved: FLUCONAZOLE — Original Application (Hospira, Inc)

  FDA approved Hospira's original application for a generic fluconazole product, an antifungal medication with indications similar to the refe…

• FDA approval · 2009-05-04
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Cancidas (caspofungin acetate) to expand its labeling.

• FDA approval · 2008-03-10
  FDA Approved: VFEND — Supplemental Application (Roerig)

  FDA approved a supplemental application for VFEND (voriconazole) filed by Roerig.

• FDA approval · 2007-08-06
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for MYCAMINE (micafungin sodium) by Astellas Pharma US, Inc.

• FDA approval · 2006-06-27
  FDA Approved: MYCAMINE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYCAMINE (micafungin sodium) from Astellas Pharma US, Inc., expanding labeling through a supplem…