Vaginal Candidiasis

• FDA approval · 2024-05-29
  FDA Approved: VAGISTAT 3 — Supplemental Application (Combe Incorporated)

  The FDA approved a supplemental application for VAGISTAT 3 (miconazole nitrate) submitted by Combe Incorporated. Miconazole nitrate is a vag…

• FDA approval · 2021-09-15
  FDA Approved: MONISTAT 3 3 DAY — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 3 3 DAY (miconazole nitrate) from Insight Pharmaceuticals LLC.

• FDA approval · 2020-07-22
  FDA Approved: MONISTAT 7 7-DAY DISPOSABLE APPLICATORS — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application to add MONISTAT 7 7-day disposable applicators (miconazole nitrate) to the product, expanding its de…

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

  FDA approved a supplemental application for MONISTAT 3 COMBINATION PACK (miconazole nitrate) from Insight Pharmaceuticals LLC. The approval …

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

  FDA approved a supplemental application to market MONISTAT 3 3 DAY (miconazole nitrate) by Insight Pharmaceuticals LLC.

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• FDA approval · 2015-11-20
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application for MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (miconazole nitrate) from Insight Pharmaceuticals LL…

• FDA approval · 2015-06-17
  FDA Approved: GYNAZOLE 1 — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for GYNAZOLE 1 (butoconazole nitrate) from Padagis Israel Pharmaceuticals Ltd, for the treatment…

• 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 · 2015-02-27
  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 · 2014-02-27
  FDA Approved: MONISTAT 7 7-DAY DISPOSABLE APPLICATORS — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application to add MONISTAT 7 7-DAY DISPOSABLE APPLICATORS (miconazole nitrate) for the treatment of vaginal can…

• FDA approval · 2013-08-13
  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, submitted by Insight …

• FDA approval · 2013-07-10
  FDA Approved: MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application to approve the MONISTAT 3 Combination Pack (three vaginal ovule inserts) containing miconazole n…

• FDA approval · 2013-07-10
  FDA Approved: MONISTAT 3 COMBINATION PACK — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for the Monistat 3 Combination Pack containing miconazole nitrate, issued to Insight Pharmaceuti…

• FDA approval · 2013-07-10
  FDA Approved: MONISTAT 3 3 DAY — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA lists a supplemental application for MONISTAT 3 3 DAY (miconazole nitrate) submitted by Insight Pharmaceuticals LLC under NDA 020827…

• FDA approval · 2013-02-06
  FDA Approved: MONISTAT 1 COMBINATION PACK — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental NDA for MONISTAT 1 COMBINATION PACK (miconazole nitrate) by Insight Pharmaceuticals LLC.

• FDA approval · 2013-01-29
  FDA Approved: MONISTAT 7 7-DAY DISPOSABLE APPLICATORS — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application to introduce MONISTAT 7 7-day disposable applicators containing miconazole nitrate, expanding th…

• 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 · 2010-12-30
  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% from E. Fougera & Co., indicating approval of a modification to t…

• FDA approval · 2010-08-03
  FDA Approved: CLOTRIMAZOLE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a generic clotrimazole product under an original ANDA from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2009-10-02
  FDA Approved: MONISTAT 3 3 DAY — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application for MONISTAT 3 3 DAY (miconazole nitrate) submitted by Insight Pharmaceuticals LLC.

• FDA approval · 2009-09-18
  FDA Approved: FLUCONAZOLE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for fluconazole from Rising Pharma Holdings, Inc., enabling the generic antifungal to enter the market…

• FDA approval · 2009-08-20
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clotrimazole from Sun Pharmaceutical Industries, Inc., updating the approved product informa…

• FDA approval · 2008-10-28
  FDA Approved: MONISTAT 3 COMBINATION PACK — Supplemental Application (Insight Pharmaceuticals LLC)

  The FDA approved a supplemental application for MONISTAT 3 COMBINATION PACK (miconazole nitrate) from Insight Pharmaceuticals LLC.

• FDA approval · 2008-09-05
  FDA Approved: MONISTAT 3 3 DAY — Supplemental Application (Insight Pharmaceuticals LLC)

  FDA approved a supplemental application for MONISTAT 3 3 DAY (miconazole nitrate) filed by Insight Pharmaceuticals LLC.

• FDA approval · 2008-09-02
  FDA Approved: CLOTRIMAZOLE — Original Application (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.)

  FDA approved the original application for clotrimazole as a generic product; the approval is held by E. Fougera & Co. a division of Fougera …