Onychomycosis

• 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.

• CLINICAL_TRIALS trial_result · 2007-09-05
  Clinical Trial Update: Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients

  This completed clinical trial assessed the prevalence of onychomycosis in patients with diabetic neuropathy and evaluated diagnostic conside…

• 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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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…

• CLINICAL_TRIALS trial_result · 2007-05-30
  Clinical Trial Update: Topical Gel Anti-Fungal Agent for Tinea Unguium [Phase 2]

  A Phase 2 trial of a topical antifungal gel for onychomycosis (tinea unguium) has completed.