Application Nr Approved Date Route Status External Links
ANDA077137 2007-07-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Terbinafine Tablets, Usp 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, Usp Are An Allylamine Antifungal Indicated For The Treatment Of Onychomycosis Of The Toenail Or Fingernail Due To Dermatophytes (tinea Unguium) (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Terbinafine Hydrochloride TERBINAFINE HYDROCHLORIDE ZINC1530981

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