Terbinafine
Drug Details
- Generic Name
- Terbinafine
- Brand Names
- TERBINAFINE, Terbinafine, Toenail Fungus Treatment
- Application Number
- ANDA078199
- Sponsor
- Chartwell RX, LLC
- NDC Codes
- 8
- Dosage Forms
- TABLET, POWDER, LIQUID
- Routes
- ORAL, TOPICAL
- Active Ingredients
- TERBINAFINE HYDROCHLORIDE, TERBINAFINE
Indications and Usage
1. INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )