Vulvovaginal 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 · 2025-08-22
  FDA Approved: TERCONAZOLE VAGINAL CREAM 0.8% — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved a supplemental application for Terconazole Vaginal Cream 0.8% (terconazole). The submission was made by E. Fougera & Co., a div…

• 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 · 2024-04-11
  FDA Approved: VIVJOA — Supplemental Application (Mycovia Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VIVJOA (oteseconazole) submitted by Mycovia Pharmaceuticals, Inc.

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• FDA approval · 2024-02-29
  FDA Approved: CLOTRIMAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved the original application for clotrimazole from Rising Pharma Holdings, enabling a generic version of this antifungal. It co…

• FDA approval · 2023-11-17
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 3 Combination Pack 3 Ovule Inserts (miconazole nitrate) for the treatment of vulvov…

• 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…

• 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 · 2022-04-26
  FDA Approved: VIVJOA — Original Application (Mycovia Pharmaceuticals, Inc.)

  FDA approved Vivjoa (oteseconazole) from Mycovia Pharmaceuticals for the treatment of recurrent vulvovaginal candidiasis, marking the first …

• 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 · 2020-07-22
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for Monistat 3 Combination Pack (3 ovule inserts) containing miconazole nitrate, expanding the p…

• 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 · 2020-01-28
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 3 Combination Pack 3 Ovule Inserts containing miconazole nitrate from Insight Pharm…

• FDA approval · 2020-01-28
  FDA Approved: MONISTAT 7 7-DAY DISPOSABLE APPLICATORS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 7 7-day disposable applicators containing miconazole nitrate, expanding the product…

• FDA approval · 2020-01-28
  FDA Approved: MONISTAT 3 COMBINATION PACK — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application to authorize the MONISTAT 3 COMBINATION PACK containing miconazole nitrate from Insight Pharmace…

• FDA approval · 2020-01-28
  FDA Approved: MONISTAT 1 COMBINATION PACK — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 1 COMBINATION PACK (miconazole nitrate) from Insight Pharmaceuticals 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 · 2016-08-25
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC))

  The FDA approved a supplemental application for clotrimazole, reflecting a regulatory update to its approval.

• FDA approval · 2016-02-23
  FDA Approved: TERCONAZOLE — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Terconazole from Cosette Pharmaceuticals, under ANDA 077553, enabling the marketed generic produ…

• FDA approval · 2016-02-20
  FDA Approved: TERCONAZOLE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved a supplemental application for terconazole by E. Fougera & Co. to update labeling for the antifungal product.

• FDA approval · 2016-01-21
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application to market MONISTAT 3 Combination Pack 3 Ovule Inserts containing miconazole nitrate. The product is …

• FDA approval · 2015-08-20
  FDA Approved: TERCONAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Terconazole submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-08-10
  FDA Approved: MONISTAT 7 7-DAY DISPOSABLE APPLICATORS — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application for MONISTAT 7 7-DAY DISPOSABLE APPLICATORS, a miconazole nitrate vaginal antifungal product, to inc…