Oropharyngeal Candidiasis

• 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 · 2025-07-03
  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 · 2025-04-25
  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 · 2025-03-21
  FDA Approved: NYSTATIN — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic Nystatin product from Aurobindo Pharma Limited under an Original Application.

• 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.

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• EMA approval · 2025-01-21
  EMA Authorised: Posaconazole AHCL (posaconazole) — Accord Healthcare S.L.U.

  EMA authorised Posaconazole AHCL by Accord Healthcare S.L.U. for mycoses. The EU marketing authorization was granted on 16 January 2025.

• 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 · 2024-10-25
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for NOXAFIL (posaconazole) from Merck Sharp & Dohme LLC.

• 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 · 2023-12-26
  FDA Approved: POSACONAZOLE — Original Application (Mylan Institutional LLC)

  FDA approves a generic posaconazole product from Mylan Institutional LLC under an Original Application (ANDA 211500). The approval indicates…

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

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

• 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…

• 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 · 2022-12-08
  FDA Approved: POSACONAZOLE — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for posaconazole, granting authorization for a generic posaconazole product (ANDA 21…

• FDA approval · 2022-07-28
  FDA Approved: POSACONAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for posaconazole delayed-release (POSACONAZOLE DELAYED-RELEASE) from Chartwell RX, LLC, updating its…

• 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 · 2021-02-01
  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 · 2020-09-16
  FDA Approved: NOXAFIL — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved Merck's supplemental application for NOXAFIL (posaconazole), updating the product labeling with new indications/usage detai…

• 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 · 2020-02-04
  FDA Approved: ORAVIG — Supplemental Application (Galt Pharmaceuticals, LLC)

  The FDA approved a supplemental application for ORAVIG (miconazole) submitted by Galt Pharmaceuticals, LLC, signaling regulatory approval to…

• 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 · 2018-05-25
  FDA Approved: NYSTATIN — Original Application (Viona Pharmaceuticals Inc)

  FDA approved NYSTATIN as an Original Application (ANDA 207767) for a generic nystatin product by Viona Pharmaceuticals Inc.

• FDA approval · 2018-05-21
  FDA Approved: NYSTATIN — Original Application (Leading Pharma, LLC)

  The FDA has approved an original ANDA for NYSTATIN from Leading Pharma, LLC.