Tinea Corporis

• 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…

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• 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…

• 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.

• FDA approval · 2009-11-24
  FDA Approved: CICLOPIROX — Original Application (Actavis Pharma, Inc.)

  FDA approves Ciclopirox as a generic topical antifungal product under an original application from Actavis Pharma, Inc.

• FDA approval · 2009-11-19
  FDA Approved: LAMISIL AT CREAM — Supplemental Application (Voyant Beauty Inc.)

  FDA approved a supplemental application for LAMISIL AT CREAM (terbinafine hydrochloride) by Voyant Beauty Inc., resulting in an expanded/upd…

• FDA approval · 2009-08-20
  FDA Approved: CLOTRIMAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clotrimazole from Sun Pharmaceutical Industries, Inc., updating the approved product informa…

• FDA approval · 2009-06-15
  FDA Approved: LAMISIL AT — Supplemental Application (Karo Healthcare Inc.)

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

• 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 · 2009-01-29
  FDA Approved: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for clotrimazole and betamethasone dipropionate from Sun Pharmaceutical, updating the labeling for t…