Tinea Pedis

• 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 · 2017-11-16
  FDA Approved: ATHLETES FOOT — Original Application (TOPCO ASSOCIATES LLC)

  FDA approved a generic version of butenafine hydrochloride for the treatment of athlete's foot (tinea pedis) under Original Application by T…

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• 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 · 2017-01-19
  FDA Approved: LOTRIMIN ULTRA ATHLETES FOOT — Supplemental Application (Bayer Healthcare LLC.)

  FDA approved a supplemental application for Lotrimin Ultra Athletes Foot (butenafine hydrochloride) by Bayer Healthcare LLC.

• 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…

• 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 approval · 2016-03-07
  FDA Approved: OXICONAZOLE NITRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Oxiconazole Nitrate topical product from Sun Pharmaceutical Industries, Inc. This generic antifungal is indicated for common fu…

• FDA approval · 2016-02-25
  FDA Approved: CICLOPIROX OLAMINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Ciclopirox olamine to update labeling and support use for common superficial fungal skin infecti…

• FDA approval · 2016-01-06
  FDA Approved: NAFTIFINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's Naftifine hydrochloride under an Original Application; it is a topical antifungal indicated for tinea corp…

• FDA approval · 2015-12-18
  FDA Approved: LOTRIMIN ULTRA ATHLETES FOOT — Supplemental Application (Bayer Healthcare LLC.)

  FDA approves Bayer's supplemental application for LOTRIMIN ULTRA ATHLETES FOOT containing butenafine hydrochloride, expanding the labeling t…

• FDA approval · 2015-10-30
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Original Application (Glenmark Pharmaceuticals Inc. USA)

  FDA approved Glenmark's generic topical combination of clotrimazole and betamethasone dipropionate (ANDA 202894). It is indicated for inflam…

• FDA approval · 2015-10-14
  FDA Approved: CICLOPIROX — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Ciclopirox from Padagis Israel Pharmaceuticals Ltd, indicating an update to the product's labeli…

• FDA approval · 2015-10-08
  FDA Approved: CICLOPIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Ciclopirox from Sun Pharmaceutical Industries, Inc., under the ANDA framework. The approval indi…

• FDA approval · 2015-09-11
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approves a supplemental application for clotrimazole and betamethasone dipropionate (topical antifungal with corticosteroid) from E. Fou…

• FDA approval · 2015-08-25
  FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for terbinafine hydrochloride (NorthStar Rx LLC). This action updates labeling/indications for the p…

• FDA approval · 2015-08-19
  FDA Approved: OXISTAT — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Oxistat (oxiconazole nitrate) from ANI Pharmaceuticals, Inc.