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FDA Approval Activities for this Drug…
Clotrimazole & Betamethasone Dipropionate Cream USP, 1%/0.5% (base), Alpharma ANDA 76-002 8/2/02 Clotrimazole & Betamethasone Diproprionate Cream,1% / 0.05% (base), Taro U.S.A., ANDA 75-673 5/29/01 6/5/01 Clotrimazole & Betamethasone Diproprionate Cream,1% / 0.05% (base), Altana ANDA 75-502 Gynix Vaginal Tablets (Clotrimazole Vaginal Tablets, USP) 100mg Copley Pharmaceutical, ANDA 73-249 Lotrimin Antifungal Cream (Clotrimazole) 1%, Schering-Plough HealthCare NDA 20-888/S2 08/01/01 04/24/03 Lotrimin Antifungal Lotion (Clotrimazole) 1%, Schering-Plough HealthCare NDA 20-889/S2 08/01/01 04/24/03 Lotrimin Antifungal Solution (Clotrimazole) 1%, Schering-Plough HealthCare NDA 20-890/S2 08/01/01 04/25/03 Lotrimin Ultra Butenafine Hydrochloride Cream, 1%, OTC Schering-Plough HealthCare NDA 21-307 12/7/01 3/26/02 3/26/02 3/26/02 Lotrisone (clotrimazole and betamethasone diproprionate) Cream, Schering NDA 18-827/S-025 3/27/03 4/15/03 4/1/03 Lotrisone (clotrimazole and betamethasone diproprionate) Cream, Schering NDA 18-827/S-022 10/3/01 7/31/03 Lotrisone (clotrimazole and betamethasone diproprionate) Cream, Schering NDA 20-010/S7, S9, S20 & S22 10/3/01 4/16/03 Lotrisone (clotrimazole and betamethasone diproprionate) Lotion, Schering NDA 20-010/S5 3/27/03 4/15/03 4/1/03 Lotrisone (clotrimazole and betamethasone diproprionate) Lotion, Schering-Plough Research Institute NDA 20-010/S3 12/17/02 1/29/03 4/4/03 Lotrisone (clotrimazole and betamethasone diproprionate) Lotion, Schering-Plough Research Institute NDA 20-010 12/8/00 3/14/01 3/14/01 Lotrisone Indications: for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton rubrum. Mycelex (clotrimazole) Troche, Bayer Pharmaceutical Division NDA 18-713/S-019 Trivagizole 3 (clotrimazole) Vaginal Cream, 2 % Taro NDA 21-143 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Cream; Topical 0.05% BASE;1% CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE ALPHARMA US | 075502 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Cream; Topical 0.05% BASE;1% CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Altana | 018827 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Cream; Topical 0.05% BASE;1% LOTRISONE SCHERING | 075673 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Cream; Topical 0.05% BASE;1% CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Taro | 020010 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE Lotion; Topical 0.05% BASE;1% LOTRISONE SCHERING PLOUGH RES | 018183 BT CLOTRIMAZOLE Cream; Topical 1% MYCELEX BAYER 017619 CLOTRIMAZOLE Cream; Topical 1% LOTRIMIN SCHERING PLOUGH | 072640 CLOTRIMAZOLE Cream; Topical 1% CLOTRIMAZOLE Taro | 018813 CLOTRIMAZOLE Lotion; Topical 1% LOTRIMIN SCHERING | 018181 AT CLOTRIMAZOLE Solution; Topical 1% MYCELEX BAYER 017613 AT CLOTRIMAZOLE Solution; Topical 1% LOTRIMIN SCHERING PLOUGH | 074580 AT CLOTRIMAZOLE Solution; Topical 1% CLOTRIMAZOLE Taro | 073306 AT CLOTRIMAZOLE Solution; Topical 1% CLOTRIMAZOLE Teva | 018713 CLOTRIMAZOLE Troche/Lozenge; 10MG MYCELEX BAYER Clotrimazole & Betamethasone Dipropionate Lotion, Taro Pharmaceuticals, Approval | Clotrimazole Lozenges, Roxane Laboratories, Approval | Clotrimazole Lozenges, Paddock Labs, Approval | Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering Corp., Labeling Revision | LOTRISONE (clotrimazole and betamethasone dipropionate) Cream, Schering-Plough, Labeling Revision | LOTRISONE (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision | Clotrimazole Topical Cream, Nycomed US Inc., Approval | Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision | Lotrisone (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision | Lotrisone (clotrimazole and betamethasone dipropionate) Cream, Schering-Plough, Labeling Revision
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