Tinea Cruris

• 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 · 2024-12-20
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved a supplemental application for a generic Terbinafine hydrochloride product from Breckenridge Pharmaceutical, Inc.

• FDA approval · 2024-09-16
  FDA Approved: KETOCONAZOLE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic ketoconazole product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 · 2023-10-16
  FDA Approved: CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% — Original Application (Allegis Holdings, LLC)

  The FDA approved Allegis Holdings' clotrimazole topical solution 1% under an Original Application (ANDA), making a generic clotrimazole topi…

• FDA approval · 2022-03-04
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved an Original Application for a generic Nystatin and Triamcinolone Acetonide topical product from Alembic Pharmaceuticals Inc.

• FDA approval · 2021-11-12
  FDA Approved: NAFTIFINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for naftifine hydrochloride submitted by Sun Pharmaceutical Industries, Inc. This action updates…

• FDA approval · 2021-05-21
  FDA Approved: KETOCONAZOLE — Original Application (Xiromed, LLC)

  FDA has approved Xiromed, LLC's original generic application for Ketoconazole Foam, a topical antifungal 2% product.

• FDA approval · 2021-05-20
  FDA Approved: KETOCONAZOLE — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals' ketoconazole cream, 2% as an original-application generic topical antifungal product (ANDA212443).

• 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…

• FDA approval · 2020-07-06
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (NORTHSTAR RX LLC)

  FDA approved a supplemental application for clotrimazole and betamethasone dipropionate topical from NorthStar RX LLC.

• 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 · 2020-02-18
  FDA Approved: KETOCONAZOLE — Supplemental Application (THIRTY MADISON INC)

  The FDA approved a supplemental application for Ketoconazole filed by Thirty Madison Inc, resulting in updates to the Ketoconazole product l…

• FDA approval · 2019-12-03
  FDA Approved: NAFTIFINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for naftifine hydrochloride from Sun Pharmaceutical Industries, Inc.

• 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 · 2019-07-18
  FDA Approved: LAMISIL AT — Supplemental Application (Karo Healthcare Inc.)

  The FDA approved a supplemental application for LAMISIL AT (terbinafine hydrochloride) from Karo Healthcare Inc.

• FDA approval · 2019-07-17
  FDA Approved: LAMISIL AT CREAM — Supplemental Application (Voyant Beauty Inc.)

  FDA approved a supplemental application for LAMISIL AT CREAM (terbinafine hydrochloride) submitted by Voyant Beauty Inc. The approval docume…

• FDA approval · 2019-04-10
  FDA Approved: NAFTIFINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Naftifine hydrochloride topical from Sun Pharmaceutical Industries under an original ANDA for treating common fungal skin i…

• FDA approval · 2019-02-28
  FDA Approved: SILKA JOCK ITCH — Supplemental Application (Genomma Lab USA, Inc.)

  FDA approved a supplemental application for SILKA JOCK ITCH (terbinafine hydrochloride) from Genomma Lab USA, Inc. The action relates to the…

• FDA approval · 2019-02-15
  FDA Approved: CLOTRIMAZOLE — Original Application (Novitium Pharma LLC)

  FDA approved the original application for clotrimazole topical from Novitium Pharma LLC, a generic topical antifungal.

• FDA approval · 2018-12-26
  FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Sandoz Inc)

  FDA approved a generic version of griseofulvin (Ultramicrosize Griseofulvin) from Sandoz Inc under an Original Application (ANDA 202805) for…

• FDA approval · 2018-10-18
  FDA Approved: LAMISIL AT — Supplemental Application (Karo Healthcare Inc.)

  The FDA approved a supplemental application for LAMISIL AT (terbinafine hydrochloride) submitted by Karo Healthcare Inc.

• FDA approval · 2018-06-18
  FDA Approved: KETOCONAZOLE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's original ANDA for Ketoconazole, a generic antifungal product, covering common dermatophytic an…