FDA Approval Activities for this Drug…

Alavert (loratadine) Orally Disintegrating Tablets, () Whitehall-Robbins NDA 21-375 12/12/02 Alavert (loratadine) Orally Disintegrating Tablets, OTC Wyeth Consumer Healthcare NDA 21-375 Claritin (loratadine) Tablets, Syrup and RediTabs, OTC Schering NDA 19-658/S-018, 20-704/S-008, & 20-641/S-009 11/27/02 12/6/02 Claritin (Loratadine) Syrup, Schering NDA 20-641/S7 12/4/00 5/16/02 5/16/02 5/16/02 Claritin (Loratadine) Tablet, Schering NDA 19658/S21 6/25/03 7/6/03 Claritin (loratadine/pseudoephedrine sulfate) D-12 and D-24 Extended Release Tablets, OTC Schering NDA 19-670/S-018 & 20-470/S-016 11/27/02 12/6/02 Claritin-D24 Hour (10 mg loratadine/240 mg pseudoephedrine sulfate, USP) Extended Release Tablets Schering NDA 20-470/S005 12/4/98 5/23/01 Claritin-D 24 Hour (10 mg loratadine/240 mg pseudoephedrine sulfate, USP) Extended Release Tablets Schering NDA 20-470/S19 Loratadine Syrup, 10 mg/10 mL, Taro ANDA 76-127 6/26/02 Loratadine Syrup, 10 mg/10 mL, OTC L. Perrigo Co. ANDA 75-728 3/12/03 Loratadine Syrup, 10 mg/10 mL, Novex Pharma ANDA 75-565 7/30/01 Loratadine Orally Disintegrating Tablets, 10 mg, OTC Impax ANDA 76-011 9/29/03 Loratadine Orally Disintegrating Tablets, 10 mg, Wyeth Consumer Healthcare ANDA 75-822 2/10/03 2/14/03 Loratadine Orally Disintegrating Tablets, 10 mg, Andrx ANDA 75-990 11/15/02 Loratadine Tablets, 10 mg, OTC Geneva ANDA 75-209 1/21/03 2/14/03 Loratadine Tablets, 10 mg, Geneva ANDA 75-209 9/13/01 Loratadine Tablets, 10 mg, Genpharm ANDA 76-154 8/20/03 Loratadine Tablets, 10 mg, Genpharm ANDA 76-154 2/28/02 4/11/03 Loratadine Tablets, 10 mg, Ranbaxy Ltd. ANDA 76-134 8/18/03 Loratadine Tablets, 10 mg, Ranbaxy Ltd. ANDA 76-134 12/20/01 4/16/03 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 5 mg/120 mg, Andrx L.L.C. ANDA 76-208 2/24/03 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 5 mg/120 mg, Impax, ANDA 76-050 1/30/03 2/14/03 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 5 mg/120 mg, Impax, ANDA 76-050 5/29/02 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 10 mg/240 mg, Impax, ANDA 75-989 5/24/02 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 10 mg/240 mg, Andrx L.L.C. ANDA 75-706 2/21/03 Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, 10 mg/240 mg, Andrx L.L.C. ANDA 75-706 7/9/02 Loratadine Tablets, 10 mg, Mylan ANDA 75-790 1/12/01 3/5/01 Loratadine Tablets, 10 mg, Mylan ANDA 75-790 1/12/01 3/5/01 Loratadine Tablets, 10 mg, Teva USA ANDA 75-722 Loratadine Orally Disintegrating Tablets, Andrx Loratadine Syrup, Teva Claritin (Loratadine) Tablet, Reditab & Syrup, Schering Loratadine Syrup, Morton Grove Pharmaceuticals, Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Andrx Pharmaceuticals, L.L.C. Loratadine and Pseudoephedrine Sulfate Extended-release Tablets, Impax Laboratories, Inc. Loratadine Syrup, Novex Pharma, Loratadine Tablets, Perrigo Company Loratadine Tablets USP, L. Perrigo Company, Approval Claritin (loratadine) Syrup, Schering Corporation, Package Change Claritin-D 24 Hour (10 mg loratadine and 240 mg pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, Labeling Revision Claritin-D 12 Hour (loratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, New or Modified Indication Claritin-D 24 Hour (loratadine and pseudoephedrine sulfate) Extended Release Tablets, Schering-Plough, New or Modified Indication Loratadine Syrup, L.Perrigo Co., Approval Loratadine Syrup, Morton Grove Pharma, Approval Loratadine Syrup, Ranbaxy Laboratories Ltd., Approval Loratadine Syrup, Taro Pharmaceutical, Approval | Loratadine and Pseudoephedrine Sulfate ER Tablets, Ranbaxy, Approval | Loratadine Syrup, Apotex Corp., Approval | Claritin (loratadine) Syrup, Schering Corp., Control Supplement

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