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Summary for Generic Name: esomeprazole magnesium
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Tentative approvals for ESOMEPRAZOLE MAGNESIUM
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Clinical Trials for: esomeprazole magnesiumViokase 16, Viokase16 Plus Nexium and Nexium Alone Status: Terminated Condition: Chronic Pancreatitis A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050 AM1)(CL2010-12) Status: Completed Condition: Heartburn Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD) Status: Completed Condition: Heartburn; Gastroesophageal Reflux Disease Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus Status: Active, not recruiting Condition: Barrett Esophagus; Esophageal Cancer A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED) Status: Completed Condition: Gastric Acid; Human Experimentation Nexium Study To Suppress Nausea During Chemotherapy Status: Terminated Condition: Nausea Courtesy of ClinicalTrials.org See more clinical trials for this drug | |||||||||||||||||||||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Patented / Exclusive Use | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Astrazeneca | NEXIUM | esomeprazole magnesium | Capsule, Delayed Rel Pellets; Oral | 021153 | FEB 20, 2001 | RX | Yes | <disabled> | NEW PRODUCT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Astrazeneca | NEXIUM | esomeprazole magnesium | Capsule, Delayed Rel Pellets; Oral | 021153 | FEB 20, 2001 | RX | Yes | 4,255,431 | <disabled> | GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING 'PERTINENT TO THE CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE' | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Astrazeneca | NEXIUM | esomeprazole magnesium | Capsule, Delayed Rel Pellets; Oral | 021153 | FEB 20, 2001 | RX | Yes | 4,508,905 | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Astrazeneca | NEXIUM | esomeprazole magnesium | Capsule, Delayed Rel Pellets; Oral | 021153 | FEB 20, 2001 | RX | Yes | 4,636,499 | <disabled> | GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING 'PERTINENT TO THE CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE' | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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