pantoprazole sodium injection

FDA Drug Profile — PANTOPRAZOLE SODIUM

Drug Details

Generic Name
pantoprazole sodium injection
Brand Names
PANTOPRAZOLE SODIUM
Application Number
ANDA219230
Sponsor
Alembic Pharmaceuticals Limited
NDC Codes
2
Dosage Forms
POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
PANTOPRAZOLE SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Pantoprazole sodium for injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. ( 1 ) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. ( 1 ) Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. ( 1 )