Application Nr Approved Date Route Status External Links
ANDA077919 2007-07-02 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Terbinafine Tablets, Usp 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 (koh Preparation, Fungal Culture, Or Nail Biopsy) Should Be Obtained To Confirm The Diagnosis Of Onychomycosis. Terbinafine Hydrochloride Tablets Are An Allylamine Antifungal Indicated For The Treatment Of Onychomycosis Of The Toenail Or Fingernail Due To Dermatophytes (tinea Unguium).

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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