Onychomycosis

• FDA approval · 2014-01-09
  FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Ultramicrosize Griseofulvin tablets from Amneal Pharmaceuticals of New York LLC via an Original Application.

• 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…

• 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 …

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• 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 · 2012-02-29
  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 · 2011-02-04
  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 · 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 · 2009-01-07
  FDA Approved: CICLOPIROX — Original Application (Padagis US LLC)

  FDA approved Padagis US LLC's original Abbreviated New Drug Application for ciclopirox, a topical antifungal.

• FDA approval · 2008-07-14
  FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Terbinafine hydrochloride by NorthStar Rx LLC. The approval confirms changes to the generic prod…

• FDA approval · 2008-04-04
  FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for Terbinafine hydrochloride (Terbinafine) submitted by NorthStar Rx LLC.

• FDA approval · 2007-09-10
  FDA Approved: GRISOFULVIN — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for griseofulvin, a generic antifungal, enabling its marketing.

• FDA approval · 2007-07-06
  FDA Approved: GRISEOFULVIN — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Griseofulvin as a generic oral antifungal indicated for dermatophyte infections such as tinea capi…

• FDA approval · 2007-07-02
  FDA Approved: TERBINAFINE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s original application for generic terbinafine, expanding access to treatment for fungal infections such as nail…

• FDA approval · 2007-07-02
  FDA Approved: TERBINAFINE HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved a generic Terbinafine hydrochloride product from Bionpharma Inc. as an original ANDA approval.

• FDA approval · 2007-07-02
  FDA Approved: TERBINAFINE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for terbinafine (generic antifungal), enabling a generic terbinafine product to enter the mar…