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Details for Generic Name: lansoprazole

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Summary for Generic Name: lansoprazole

Drug Master File Entries: see list49
Suppliers: see list9
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: lansoprazole

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Clinical Trials for: lansoprazole

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis
Status: Completed Condition: Esophagitis; Reflux

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Status: Completed Condition: Frequent Heartburn

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
Status: Completed Condition: Gastroesophageal Reflux Disease

Lansoprazole for Subgroups of Functional Dyspepsia
Status: Terminated Condition: Functional Dyspepsia

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
Status: Completed Condition: Bioavailability

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Status: Withdrawn Condition: Chest Pain; Gastrointestinal Reflux Disease

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
Status: Completed Condition: Stomach Ulcer

Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Status: Completed Condition: Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms Inc
Takeda Pharms Na
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507Nov 14, 2003DISCNNo<disabled><disabled>
Takeda Pharms Usa
CAPSULE, DELAYED REL PELLETS;ORAL020406May 10, 1995RXNo<disabled><disabled>
CAPSULE, DELAYED REL PELLETS;ORAL022327May 18, 2009OTCYes<disabled><disabled>
Takeda Pharms Usa
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428Aug 30, 2002RXYes7,875,292*PED<disabled>Y<disabled>
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