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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. | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, New or Modified Indication | Nexium I.V. (esomeprazole sodium) Injection, AstraZeneca LP, Approval
For the most up-to-date approval information, please locate this API using the drug index.
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