Cryptococcal Meningitis

• FDA approval · 2026-01-14
  FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride (intravenous formulation), adding this generic IV flu…

• FDA approval · 2025-04-25
  FDA Approved: FLUCONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for fluconazole by Hikma Pharmaceuticals USA Inc., advancing the approval of this generic antifu…

• FDA approval · 2024-06-25
  FDA Approved: FLUCONAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Fluconazole from Dr. Reddy's Laboratories Limited (ANDA 076658).

• FDA approval · 2023-10-24
  FDA Approved: FLUCONAZOLE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for fluconazole submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-07-14
  FDA Approved: FLUCONAZOLE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter Healthcare Company's supplemental application for fluconazole (ANDA076766). This action confirms authorization of a gene…

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• FDA approval · 2023-03-17
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for fluconazole submitted by Rising Pharma Holdings, Inc., indicating approval of a generic formulat…

• FDA approval · 2022-11-17
  FDA Approved: AMPHOTERICIN B — Original Application (Eugia US LLC)

  FDA approved the original ANDA for Amphotericin B from Eugia US LLC, authorizing a generic Amphotericin B product.

• FDA approval · 2021-12-14
  FDA Approved: AMPHOTERICIN B — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' original application for Amphotericin B, confirming a generic version of the antifungal. The…

• 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 · 2021-10-06
  FDA Approved: FLUCONAZOLE — Supplemental Application (Rising Pharma Holdings, Inc.)

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

• 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 · 2019-07-16
  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 · 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 · 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.

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

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

• 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 · 2012-01-30
  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 · 2011-06-28
  FDA Approved: FLUCYTOSINE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approved a generic version of Flucytosine from Sigmapharm Laboratories via an original ANDA.

• 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.