Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com