Invasive Fungal Infections

• FDA approval · 2025-07-03
  FDA Approved: POSACONAZOLE — Supplemental Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved a supplemental application for posaconazole submitted by Glenmark Pharmaceuticals Inc., USA, under an ANDA.

• FDA approval · 2025-03-13
  FDA Approved: POSACONAZOLE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for posaconazole from Mylan Institutional LLC, updating the approval for the generic product.

• FDA approval · 2024-12-23
  FDA Approved: POSACONAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' posaconazole under an Original Application (ANDA), marking a generic approval for this antifungal.

• FDA approval · 2024-10-24
  FDA Approved: POSACONAZOLE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for posaconazole (POSACONAZOLE), approving the generic product.

• FDA approval · 2023-08-28
  FDA Approved: POSACONAZOLE — Original Application (i3 Pharmaceuticals, LLC)

  FDA approved an original application for posaconazole from i3 Pharmaceuticals, LLC (generic posaconazole).

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• FDA approval · 2022-05-25
  FDA Approved: POSACONAZOLE — Original Application (Par Health USA, LLC)

  FDA approved the original application for posaconazole (generic) by Par Health USA, LLC, marking the availability of a generic posaconazole …

• FDA approval · 2022-02-04
  FDA Approved: POSACONAZOLE — Original Application (Biocon Phama Inc.)

  FDA approved Biocon Phama Inc.'s original application for posaconazole, authorizing a generic formulation of the antifungal agent.

• 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 · 2021-02-01
  FDA Approved: POSACONAZOLE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the original application for posaconazole from Lupin Pharmaceuticals, enabling generic availability of the antifungal.

• 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 · 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 · 2015-02-27
  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 · 2014-10-23
  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 · 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 · 2010-03-05
  FDA Approved: AMPHOTERICIN B — Supplemental Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved a supplemental application for Amphotericin B submitted by XGen Pharmaceuticals DJB, Inc. This approval authorizes a change to …

• FDA approval · 2006-09-15
  FDA Approved: NOXAFIL — Original Application (Merck Sharp & Dohme LLC)

  NOXAFIL (posaconazole) received FDA approval through its original application as a broad-spectrum antifungal agent for the prevention of inv…