Histoplasmosis

• EMA approval · 2026-06-12
  EMA Authorised: Posaconazole Accord (posaconazole) — Accord Healthcare S.L.U.

  Authorised status for Posaconazole Accord, MAH Accord Healthcare S.L.U., in the therapeutic area of mycoses.

• FDA approval · 2025-06-02
  FDA Approved: AMPHOTERICIN B — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original application for Amphotericin B as a generic drug by Heritage Pharmaceuticals (Avet) to treat serious systemic funga…

• FDA approval · 2025-03-12
  FDA Approved: ITRACONAZOLE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for itraconazole from Ascend Laboratories, LLC, authorizing changes to the generic product under AND…

• FDA approval · 2025-01-29
  FDA Approved: ITRACONAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for itraconazole by Camber Pharmaceuticals, expanding/updating labeling for the generic product.

• FDA approval · 2024-10-24
  FDA Approved: ITRACONAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for itraconazole from Alembic Pharmaceuticals Inc., resulting in a label-related approval update for…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-07-17
  FDA Approved: FLUCONAZOLE IN SODIUM CHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for Fluconazole in Sodium Chloride, establishing an intravenous formulation of fluconazole. …

• 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 · 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 · 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…

• FDA approval · 2015-10-30
  FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original ANDA for itraconazole, enabling a generic version of the antifungal agent to be marketed.

• 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 · 2011-08-25
  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 · 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 …