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FEXOFENADINE

 
 

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FDA Approval Activities for this Drug…

Allegra (fexofenadine hydrochloride) Capsules 60 mg. Aventis NDA 20-625 7/25/96 4/30/03 | Allegra (fexofenadine hydrochloride) Capsules and Tablets, 30, 60, and 180 mg. Aventis NDA 20-872 2/25/00 2/29/00 2/29/00 2/19/02 | Allegra (Fexofenadine HCl) Tablets Aventis NDA 20-872/S1, 2 & 4 10/29/01 11/8/01 11/8/01 | Allegra (fexofenadine HCl) Capsules and Tablets, Aventis NDA 20-625/S12, 20-872/S11 & 20-786/S14 5/12/03 7/10/03 7/10/03 | Allegra (fexofenadine HCl) Capsules and Tablets, Aventis NDA 20-625/S-010 NDA 20-872/S-003 5/12/03 7/10/03 7/10/03 | Allegra Capsules (fexofenadine HCl) and Allegra Tablets (fexofenadine HCl). Aventis NDA 20-625/S-011 NDA 20-872/S-007 7/11/01 11/25/02 | Allegra-D (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) Extended-Release tablets. Aventis NDA 20-786/S-012 | FEXOFENADINE HYDROCHLORIDE Capsule; 60MG ALLEGRA AVENTIS 020872 FEXOFENADINE HYDROCHLORIDE Tablet; 180MG ALLEGRA AVENTIS | 020872 FEXOFENADINE HYDROCHLORIDE Tablet; 30MG ALLEGRA AVENTIS | 020872 FEXOFENADINE HYDROCHLORIDE Tablet; 60MG ALLEGRA AVENTIS 020786 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Tablet, Extended Release; 60MG;120MG ALLEGRA-D AVENTIS Fexofenadine HCl & Pseudoephedrine HCl Extended-Release Tablets, Impax Laboratories, Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride, Mylan Pharmaceuticals, Inc., Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, Barr Laboratories | Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120mg) Extended-Release Tablets, Aventis, Labeling Revision | Fexofenadine Hydrochloride Capsules, Barr Laboratories, Approval | Fexofenadine Hydrochloride Tablet, Teva Pharma, Tentative Approval | Allegra (fexofenadine) tablets, Aventis Pharma, New Dosage Regimen | Fexofenadine Hydrochloride Tablets, Mylan Pharma, Tentative Approval | Allegra (fexofenadine hydrochloride) Oral Suspension, Sanofi Aventis, Approval | Fexofenadine Hydrochloride (180mg) Tablets, Mylan Pharma, Approval | Fexofenadine Hydrochloride Tablets, Ranbaxy Labs, Tentative Approval | Allegra (fexofenadine hydrochloride) Orally Disintegrating Tablets, Sanofi-aventis, Approval | Allegra (fexofenadine hydrochloride) Oral Suspension, Sanofi-Aventis US, LLC, Labeling Revision | Allegra (fexofenadine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision | Fexofenadine Hydrochloride Tablets, Sandoz Inc., Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Limited, Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Sandoz Inc., Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories, Approval | Allegra-D 12 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision | Allegra-D 24 Hour (fexofenadine hydrochloride and pseudoephedrinie hydrochloride) Extended-Release Tablets, Sanofi-Aventis, Labeling Revision | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, Wockhardt Limited, Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories Inc., Tentative Approval | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Impax Laboratories, Inc., Approval | Allegra (fexofenadine hydrochloride) Orally-Disintegrating Tablets, Sanofi-aventis, LLC, Efficacy Supplement with Clinical Data to Support | Allegra (fexofenadine hydrochloride) Tablets, Sanofi-aventis, LLC, Efficacy Supplement with Clinical Data to Support | Allegra-D 12 Hour (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets, Sanofi-aventis, LLC, Efficacy Supplement with Clinical Data to Support | Allegra-D 24 Hour (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets, Sanofi-aventis, LLC, Efficacy Supplement with Clinical Data to Support | Children’s Fexofenadine Hydrochloride Tablets, Teva Pharmaceuticals, Supplement | Fexofenadine Hydrochloride Tablets USP, Dr. Reddy’s Laboratories Ltd., Supplement | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, Dr. Reddy's Laboratories, Ltd., Tentative Approval

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