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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 | Terbinafine Hydrochloride Tabelts, Roxane Labs, Tentative Approval | Terbinafine Hydrochloride Tablet, Genpharm, Tentative Approval | Terbinafine Hydrochloride Cream, Taro Pharma, Tentative Approval | Terbinafine Hydrochloride Tablet, Watson Labs, Tentative Approval | Lamisil AT (1 % terbinafine) Gel, Novartis, Approval | Terbinafine Hydrochloride Tablet, InvaGen Pharma, Tentative Approval | Terbinafine Hydrochloride Tablets, Wockhardt Ltd., Tentative Approval | Terbinafine Hydrochloride Tablets, Wockhardt, Tentative Approval | Terbinafine Hydrochloride Tablets, Amneal Pharma, Tentative Approval | Terbinafine Hydrochloride Tablet, Apotex Inc., Tentative Approval | Terbinafine Hydrochloride Tablets, Orchid Healthcare, Tentative Approval | Terbinafine Hydrochloride Tablets, Glenmark Pharma, Tentative Approval | Terbinafine Hydrochloride Tablets, Orchid Healthcare, Approval | Terbinafine Hydrochloride Tablets, Apotex Inc., Approval | Terbinafine Hydrochloride Topical Cream, Taro Pharma, Approval | Terbinafine Hydrochloride Tablets, Watson Labs, Approval | Terbinafine Hydrochloride Tablets, Mylan Pharma, Approval | Terbinafine Hydrochloride Tablets, Geodon Richter, Approval | Terbinafine Hydrochloride Tablets, Roxane Labs, Approval | Terbinafine Hydrochloride Tablets, Teva Pharma, Approval | Terbinafine Hydrochloride Tablets, Aurobindo Pharma, Approval | Terbinafine Hydrochloride Tablets, Dr. Reddy’s Labs, Approval | Terbinafine Hydrochloride Tablets, Genpharm Inc., Approval | Terbinafine Hydrochloride Tablets, Amneal Pharma, Approval | Terbinafine Hydrochloride Tablets, Wockhart, Approval | Lamisil AT (terbinafine hydrochloride) Cream, Novartis, Labeling Revision | LAMISIL (terbinafine hydrochloride) Oral Granules, Novartis Pharma, Approval | Terbinafine Hydrochloride Tablets, Aurobindo Pharma, Control Supplement | Lamisil AT (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Package Change | Lamisil AT (terbinafine hydrochloride) Topical Spray, Novartis Consumer Health, Inc., Package Change
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