FDA Approval Activities for this Drug…

Lamisil (terbinafine gel) DermGel, 1%, Dear Health Professional Letter Novartis Pharmaceutical NDA 20-846/S-001 7/26/99 8/4/99 8/4/99 Lamisil Indication: for Tinea Lamisil/terbinafine Dermgel, 1%,Dear Health Professional Letter Novartis NDA 20-846 4/29/98 5/6/98 5/8/98 2/4/99 Lamisil (terbinafine Hydrochloride) Cream, 1% , to OTC switch, Dear Health Professional Letter Novartis NDA 20-980 3/10/99 6/28/99 Lamisil Cream Indications: Application provides for use without prescription of Lamisil (terbinafine hydrochloride cream) Cream, 1%, for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm), due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Lamisil AT (terbinafine hydrochloride) Spray Pump Solution, 1%, Dear Health Professional Letter Novartis Consumer Health, NDA 21-124 3/17/00 3/31/00 3/31/00 5/15/02 Lamisil (terbinafine hydrochloride solution) Solution, 1%, Novartis Consumer Health, NDA 20-749/S-004 3/27/03 4/15/03 4/1/03 Lamisil (terbinafine hydrochloride) Tablets Novartis NDA 20-539/S-010 Terbinafine Hydrochloride Tablets, Dr. Reddy's Laboratories, Terbinafine Hydrochloride Tablets, Teva Pharmaceuticals, Lamisil (terbinafine hydrochloride) Tablets, Novartis Pharmaceuticals Corporation Terbinafine Hydrochloride Tablets, Andrx Pharmaceuticals | Terbinafine Hydrochloride Tablet, Gedeon Richter, Tentative Approval | Terbinafine Hydrochloride Tablets, Mylan Pharma, Tentative Approval

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