Esophageal Candidiasis

• FDA approval · 2022-05-09
  FDA Approved: VORICONAZOLE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for a generic voriconazole product, enabling marketing of a generic antifung…

• FDA approval · 2021-10-25
  FDA Approved: DIFLUCAN — Supplemental Application (Roerig)

  The FDA approved a supplemental application for Diflucan (fluconazole) submitted by Roerig.

• FDA approval · 2021-07-09
  FDA Approved: MICAFUNGIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original ANDA for micafungin sodium injectable (micafungin).

• FDA approval · 2021-07-09
  FDA Approved: MICAFUNGIN — Original Application (Sagent Pharmaceuticals)

  FDA approved the Original Application for micafungin sodium from Sagent Pharmaceuticals, resulting in a generic micafungin product. The appr…

• FDA approval · 2021-06-16
  FDA Approved: MICAFUNGIN — Original Application (Par Health USA, LLC)

  FDA approved a micafungin product via an original NDA submitted by Par Health USA, LLC.

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• FDA approval · 2020-10-05
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA approves a supplemental application for ERAXIS (anidulafungin) submitted by Roerig.

• FDA approval · 2020-06-22
  FDA Approved: FLUCONAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fluconazole submitted by Chartwell RX, LLC.

• FDA approval · 2019-09-05
  FDA Approved: CASPOFUNGIN ACETATE — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Caspofungin acetate submitted by Sagent Pharmaceuticals.

• FDA approval · 2019-07-16
  FDA Approved: FLUCONAZOLE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Fluconazole from Zydus Lifesciences Limited, resulting in regulatory approval of this generic pr…

• FDA approval · 2019-05-17
  FDA Approved: MICAFUNGIN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original ANDA for micafungin sodium (Micafungin), a generic echinocandin antifungal. The approval cov…

• FDA approval · 2018-11-30
  FDA Approved: VORICONAZOLE — Original Application (Slate Run Pharmaceuticals)

  FDA approved voriconazole under an original application for Slate Run Pharmaceuticals.

• FDA approval · 2018-03-13
  FDA Approved: CANCIDAS — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approves a supplemental application for Cancidas (caspofungin acetate) to update labeling and/or expand its indications, as part of Merc…

• FDA approval · 2018-01-05
  FDA Approved: ERAXIS — Supplemental Application (Roerig)

  FDA approved a supplemental application for ERAXIS (anidulafungin) submitted by Roerig to update/expand the product labeling.

• FDA approval · 2017-03-09
  FDA Approved: VORICONAZOLE — Original Application (Xellia Pharmaceuticals USA LLC)

  FDA approved voriconazole via an Original Application submitted by Xellia Pharmaceuticals USA LLC (NDA208562).

• FDA approval · 2016-12-30
  FDA Approved: CASPOFUNGIN ACETATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved caspofungin acetate for the treatment of invasive candidiasis (including candidemia) and esophageal candidiasis.

• FDA approval · 2016-05-31
  FDA Approved: VORICONAZOLE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approval of Lupin's original application for a generic voriconazole product used to treat invasive fungal infections, including invasive…

• FDA approval · 2016-05-24
  FDA Approved: VORICONAZOLE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Voriconazole from Zydus Lifesciences Limited, granting approval for a generic Voriconazole product…

• FDA approval · 2016-05-24
  FDA Approved: VORICONAZOLE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved a generic version of voriconazole from Ajanta Pharma USA Inc. under an Original Application, for treatment of invasive aspergil…

• 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 · 2016-01-22
  FDA Approved: VORICONAZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved Voriconazole from Aurobindo Pharma Limited via an Original Application (ANDA), introducing a generic version of voriconazole. T…

• FDA approval · 2016-01-12
  FDA Approved: VORICONAZOLE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Voriconazole submitted by Mylan Pharmaceuticals.

• FDA approval · 2015-10-23
  FDA Approved: VORICONAZOLE — Supplemental Application (Sandoz Inc)

  FDA approves a supplemental application for voriconazole (VORICONAZOLE) from Sandoz Inc.

• FDA approval · 2015-09-02
  FDA Approved: VORICONAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original application for a generic Voriconazole (ANDA 203503), enabling the generic antifungal to be marketed in…

• 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…