Details for New Drug Application (NDA): 020192
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The generic ingredient in LAMISIL is terbinafine. There are twenty-seven drug master file entries for this compound. Additional details are available on the terbinafine profile page.
Summary for 020192
Tradename: | LAMISIL |
Applicant: | Novartis |
Ingredient: | terbinafine hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 30, 1992 | TE: | RLD: | No |
Expired US Patents for NDA 020192
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | LAMISIL | terbinafine hydrochloride | CREAM;TOPICAL | 020192-001 | Dec 30, 1992 | 4,755,534*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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