|
|
|
 |
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 | Nexium (esomeprazole magnesium) Delayed-Release Capsules, Astra Zeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Injection, Astra Zeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Patient Population Altered | Nexium (esomeprazole magnesium) Delayed-Release Capsules, Astra Zeneca, Labeling Revision | Nexium IV (esomeprazole sodium) Injection, Astra Zeneca, Labeling Revision | Nexium IV (esomeprazole sodium) for Injection, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed – Release Capsules, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, New or Modified Indication | NEXIUM Delayed Release Oral Suspension, AstraZeneca, Approval | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Injection, AstraZeneca, Labeling Revision | Esomeprazole Magnesium Delayed-Release Capsules, Ranbaxy Labs, Tentative Approval | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, Approval | Nexium IV (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed Release Oral Suspension, AstraZeneca, Efficacy Supp. w/Clinical Data | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision | Vimovo (naproxen/esomeprazole) | Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Solution, AstraZeneca, Labeling Revision | Nexium IV (esomeprazole sodium) Intravenous Injection, AstraZeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Injection, AstraZeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Efficacy Supplement | Vimovo (naproxen/esomeprazole magnesium) Tablet, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, LP, Labeling Revision | Nexium (esomeprazole sodium) Injection, AstraZeneca, LP, Labeling Revision | VIMOVO (naproxen and esomeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, LP, Efficacy Supplement with Clinical Data to Support
  
|