Tinea Cruris

• CLINICAL_TRIALS trial_result · 2013-08-28
  Clinical Trial Update: Topical Antifungal Treatment for Tinea Cruris [Phase 3]

  A Phase 3 clinical trial evaluating a topical antifungal treatment for tinea cruris has completed.

• FDA approval · 2013-06-27
  FDA Approved: NAFTIN — Original Application (Legacy Pharma USA Inc.)

  FDA approved NAFTIN (naftifine hydrochloride) under an Original Application from Legacy Pharma USA Inc. for topical treatment of dermatophyt…

• FDA approval · 2013-05-21
  FDA Approved: CICLOPIROX OLAMINE — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Ciclopirox Olamine from Cosette Pharmaceuticals, resulting in updated labeling for its topical a…

• FDA approval · 2013-02-05
  FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for terbinafine hydrochloride products from NorthStar Rx LLC. This action confirms continued ava…

• CLINICAL_TRIALS trial_result · 2013-01-23
  Clinical Trial Update: Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis [Phase 3]

  A Phase 3 trial evaluating the safety of a topical antifungal treatment for tinea pedis, tinea cruris, and tinea corporis has completed.

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• 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 · 2012-10-22
  FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Sigmapharm Laboratories, LLC)

  FDA approved the original application (ANDA) for ULTRAMICROSIZE GRISEOFULVIN from Sigmapharm Laboratories, LLC.

• FDA approval · 2012-06-28
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Limited)

  FDA approved a supplemental application for terbinafine hydrochloride tablets (250 mg) from Dr. Reddy's Laboratories Limited, authorizing a …

• CLINICAL_TRIALS trial_result · 2012-04-12
  Clinical Trial Update: Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections [Phase 3]

  This update covers a Phase 3 trial assessing the efficacy and safety of Tolnaftate Cream for fungal infections such as tinea pedis, tinea cr…

• FDA approval · 2012-04-10
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  FDA approves Breckenridge Pharmaceutical's supplemental application for terbinafine hydrochloride, a generic antifungal, to market an additi…

• FDA approval · 2012-03-20
  FDA Approved: LAMISIL AT CREAM — Supplemental Application (Voyant Beauty Inc.)

  FDA approved a supplemental application for LAMISIL AT CREAM (terbinafine hydrochloride) with Voyant Beauty as the manufacturer.

• FDA approval · 2012-03-20
  FDA Approved: LAMISIL AT — Supplemental Application (Karo Healthcare Inc.)

  FDA approved a supplemental application for LAMISIL AT (terbinafine hydrochloride) submitted by Karo Healthcare Inc., representing an additi…

• CLINICAL_TRIALS trial_result · 2012-03-13
  Clinical Trial Update: Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris [Phase 3]

  A Phase 3 multicenter trial evaluated the safety and efficacy of NAFT-500 for tinea cruris (jock itch); results from the completed study hav…

• FDA approval · 2012-02-29
  FDA Approved: CICLOPIROX — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's ciclopirox as a generic product under an original ANDA application.

• FDA approval · 2011-12-14
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Terbinafine Hydrochloride by Bionpharma Inc., signaling an approval of a supplemental submission…

• FDA approval · 2011-09-21
  FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Terbinafine hydrochloride from NorthStar Rx LLC, updating the generic product's approval.

• FDA approval · 2011-02-23
  FDA Approved: CICLOPIROX — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's Ciclopirox as an original ANDA, authorizing the generic topical antifungal 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 · 2010-12-20
  FDA Approved: CICLOPIROX OLAMINE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves the original ANDA for Ciclopirox Olamine topical product from Cosette Pharmaceuticals, a generic antifungal treatment. The prod…

• FDA approval · 2010-10-08
  FDA Approved: GRISEOFULVIN — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Griseofulvin from Cosette Pharmaceuticals in an Original Application (ANDA065438). This approval provides a generic Griseofulvi…

• FDA approval · 2010-09-17
  FDA Approved: NIZORAL — Supplemental Application (Kramer Laboratories)

  FDA approved a supplemental application for NIZORAL (ketoconazole) from Kramer Laboratories, resulting in labeling updates for the product.

• 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 · 2010-02-16
  FDA Approved: CICLOPIROX — Original Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved Padagis Israel Pharmaceuticals Ltd's Ciclopirox topical product under Original Application (ANDA 078594), authorizing its m…

• FDA approval · 2010-02-12
  FDA Approved: LAMISIL AT — Supplemental Application (Karo Healthcare Inc.)

  FDA approved a supplemental application for LAMISIL AT (terbinafine hydrochloride) from Karo Healthcare Inc. under NDA 021124. This action u…

• FDA approval · 2010-01-15
  FDA Approved: BASIC CARE MICONAZOLE 3 — Original Application (Amazon.com Services LLC)

  FDA approved BASIC CARE MICONAZOLE 3 (miconazole nitrate) via an Original Application (ANDA) for topical antifungal use.