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… Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S16 8/1/03 8/15/03 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S15 9/30/02 10/2/02 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S14 9/23/02 9/27/02 ACIPHEX (rabeprazole sodium) Delayed-Release Tablets, 20 mg. Eisai Medical Research NDA 21-456 NDA 20-973/S-013 11/8/02 11/18/02 11/8/02 4/25/03 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S12 5/29/02 6/3/02 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S9 2/12/02 2/21/02 2/21/02 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973/S8 08/15/01 04/25/03 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Eisai NDA 20-973 | Aciphex (rabeprazole sodium) Delayed-Release Tablets, Eisai Medical, Labeling Revision | Rabeprazole Sodium Delayed Release, Mylan Pharma, Tentative Approval | Rabeprazole Sodium Delayed Release Tablets, Teva Pharmaceuticals, Tentative Approval | Rabeprazole Sodium Delayed-release Tablets, Teva Pharma, Approval | Aciphex (rabeprazole sodium) Delayed-Release Tablets, Eisai Medical Research, Inc., Patient Population Altered ^ 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