Candidiasis

• FDA approval · 2017-07-07
  FDA Approved: FLUCYTOSINE — Original Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for Flucytosine (generic) to market the drug in the United States.

• 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 · 2017-05-30
  FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)

  FDA approved Leading Pharma, LLC's Original Application (ANDA208838) to market a generic nystatin product (Nystatin). This represents the fi…

• FDA approval · 2016-10-24
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Nystatin and Triamcinolone Acetonide as an Original Application (ANDA) for a topical combination product indicated f…

• FDA approval · 2016-09-26
  FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for itraconazole, granting a generic version of the antifungal medication. Th…

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• FDA approval · 2016-05-24
  FDA Approved: VORICONAZOLE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' generic voriconazole through an Original Application (ANDA); the product is indicated for treating invas…

• FDA approval · 2016-04-13
  FDA Approved: VORICONAZOLE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's original-application generic Voriconazole (voriconazole) for its approved antifungal indications.

• FDA approval · 2016-01-07
  FDA Approved: NYSTATIN — Original Application (Pharmaceutical Associates, Inc.)

  FDA approved a generic Nystatin product from Pharmaceutical Associates, Inc. under an original application (ANDA).

• FDA approval · 2015-10-14
  FDA Approved: CICLOPIROX — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Ciclopirox from Padagis Israel Pharmaceuticals Ltd, indicating an update to the product's labeli…

• FDA approval · 2015-08-31
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  FDA approved a supplemental application for Ketoconazole from Thirty Madison Inc under an existing ANDA, signaling an approved modification …

• 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 · 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 · 2015-01-05
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for clotrimazole submitted by Rite Aid Corporation, indicating an updated/expanded approval for this…

• FDA approval · 2014-01-07
  FDA Approved: DIFLUCAN — Supplemental Application (Roerig)

  The FDA approved a Roerig supplemental application for DIFLUCAN (fluconazole).

• FDA approval · 2012-06-21
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC, indicating an update to the NDA under t…

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

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic fluconazole to treat fungal infections, including candidias…

• 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 · 2011-08-25
  FDA Approved: KETOCONAZOLE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's Ketoconazole original application (ANDA 091550) for a generic ketoconazole 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 · 2011-02-04
  FDA Approved: KETOCONAZOLE — Supplemental Application (Northstar Rx LLC)

  The FDA approved a supplemental application for Ketoconazole submitted by Northstar Rx LLC.

• 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…