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