Tinea Corporis

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

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

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• 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…

• 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 · 2018-04-30
  FDA Approved: NAFTIN — Supplemental Application (Legacy Pharma USA Inc.)

  FDA approved a supplemental application for NAFTIN (naftifine hydrochloride) submitted by Legacy Pharma USA Inc. The action approves an upda…

• 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 · 2018-02-20
  FDA Approved: LUZU — Supplemental Application (Bausch Health US, LLC)

  The FDA has approved a supplemental application for LUZU (luliconazole) submitted by Bausch Health US, LLC.

• FDA approval · 2017-12-26
  FDA Approved: NYSTATIN AND TRIAMCINOLONE ACETONIDE — Original Application (Crown Laboratories)

  FDA approved an original application for Nystatin and Triamcinolone Acetonide topical, a generic product from Crown Laboratories.

• FDA approval · 2017-08-25
  FDA Approved: UP AND UP MICONAZOLE — Supplemental Application (Target Corporation)

  FDA approved a supplemental application for UP AND UP MICONAZOLE (miconazole nitrate) by Target Corporation, indicating a labeling or indica…

• FDA approval · 2017-08-21
  FDA Approved: MICONAZOLE 3 — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for MICONAZOLE 3 (miconazole nitrate) by Rite Aid Corporation.

• FDA approval · 2017-02-08
  FDA Approved: LUZU — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for LUZU (luliconazole) submitted by Bausch Health US, LLC.

• FDA approval · 2017-01-23
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Actavis Pharma's clotrimazole and betamethasone dipropionate topical product, indicating cha…

• 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 · 2016-12-13
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)

  FDA approved Glenmark's supplemental application for Clotrimazole and Betamethasone Dipropionate. The approval updates the labeling for this…

• CLINICAL_TRIALS trial_result · 2016-10-28
  Clinical Trial Update: An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis [Phase 4]

  This document reports the completion of an open-label pharmacokinetic Phase 4 study of Naftin for tinea corporis.

• CLINICAL_TRIALS trial_result · 2016-10-28
  Clinical Trial Update: Pediatric Subjects With Tinea Corporis [Phase 4]

  Phase 4 clinical trial update for pediatric subjects with tinea corporis, sponsored by Merz North America; study status is completed.

• FDA approval · 2016-09-08
  FDA Approved: NAFTIFINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' naftifine hydrochloride topical product under an Original Application.

• 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 · 2016-08-01
  FDA Approved: ECOZA — Supplemental Application (Resilia Pharmaceuticals, Inc.)

  FDA approves a supplemental application for ECOZA (econazole nitrate) from Resilia Pharmaceuticals, Inc.

• FDA label_change · 2016-06-07
  FDA Approved: LUZU — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for LUZU (luliconazole) to update its labeling.