Dermatophytosis

• FDA approval · 2025-09-12
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Terbinafine hydrochloride from Bionpharma Inc., approving a generic antifungal product under the…

• FDA approval · 2025-03-20
  FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Ultramicrosize Griseofulvin tablets from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2025-03-07
  FDA Approved: KETOCONAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approves the Original Application for Ketoconazole submitted by Viona Pharmaceuticals Inc, granting approval of a generic ketoconazole p…

• FDA approval · 2021-08-17
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for a topical Nystatin and Triamcinolone Acetonide product from Macleods Pharmaceuticals Limited for t…

• FDA approval · 2020-07-06
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's supplemental approval for the clotrimazole and betamethasone dipropionate topical product. The action approves…

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• FDA approval · 2020-05-29
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)

  FDA approved a supplemental application for clotrimazole and betamethasone dipropionate from Glenmark Pharmaceuticals USA, authorizing an up…

• FDA approval · 2019-07-25
  FDA Approved: CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% — Original Application (TruPharma LLC)

  FDA approved TruPharma LLC's clotrimazole topical solution 1% as an original application (ANDA) for treatment of common cutaneous fungal inf…

• FDA approval · 2018-05-31
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves the original application for the generic topical combination Nystatin and Triamcinolone Acetonide by Lupin Pharmaceuticals for …

• FDA approval · 2018-04-18
  FDA Approved: ECONAZOLE NITRATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for econazole nitrate from Aurobindo Pharma Limited, enabling a generic topical antifungal product.

• FDA approval · 2017-08-14
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic Nystatin and Triamcinolone Acetonide Cream under an Original Application by Padagis Israel Pharmaceuticals Ltd. It is…

• FDA approval · 2016-12-20
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's Nystatin and Triamcinolone Acetonide as an Original Application (ANDA) for a topical antif…

• FDA approval · 2016-10-24
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Nystatin and Triamcinolone Acetonide as an Original Application (ANDA) for a topical combination product indicated f…

• FDA approval · 2015-08-31
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  FDA approved a supplemental application for Ketoconazole from Thirty Madison Inc under an existing ANDA, signaling an approved modification …

• FDA approval · 2015-07-15
  FDA Approved: ECONAZOLE NITRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for econazole nitrate from Sun Pharmaceutical Industries, Inc., resulting in an approved update rela…

• FDA approval · 2015-03-03
  FDA Approved: OXISTAT — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for OXISTAT (oxiconazole nitrate) submitted by ANI Pharmaceuticals. The update modifies the labe…

• FDA approval · 2015-01-05
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for clotrimazole submitted by Rite Aid Corporation, indicating an updated/expanded approval for this…

• FDA approval · 2014-01-09
  FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Ultramicrosize Griseofulvin tablets from Amneal Pharmaceuticals of New York LLC via an Original Application.

• FDA approval · 2013-01-03
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  FDA approves a supplemental application for ketoconazole submitted by Thirty Madison Inc (ANDA076942).

• 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 · 2011-02-04
  FDA Approved: KETOCONAZOLE — Supplemental Application (Northstar Rx LLC)

  The FDA approved a supplemental application for Ketoconazole submitted by Northstar Rx LLC.

• FDA approval · 2009-03-18
  FDA Approved: KETOCONAZOLE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved a supplemental ANDA for Ketoconazole, a generic antifungal product from E. Fougera & Co. (division of Fougera Pharmaceuticals).

• FDA approval · 2007-09-10
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for clotrimazole by Padagis US LLC.

• FDA approval · 2007-09-10
  FDA Approved: GRISOFULVIN — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for griseofulvin, a generic antifungal, enabling its marketing.

• FDA approval · 2007-07-02
  FDA Approved: TERBINAFINE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for generic terbinafine, expanding access to treatment for fungal infections such as nail…