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

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