Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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,   For the latest approval information, locate this drug using this index.