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… Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153/S-5 9/19/02 9/24/02 10/15/03 Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153/S-4 2/27/03 3/10/03 Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153 & 21-154 2/20/01 4/23/03 9/7/01 Nexium Indications: N21-153: 1) healing of erosive esophagits; 2) maintenance of healing of erosive esophagitis; and 3) treatment of symptomatic gastroesophageal reflux disease. N21-154: Nexium in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease. Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P.   For the latest approval information, locate this drug using this index.