Application Nr Approved Date Route Status External Links
ANDA202686 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Esomeprazole Sodium For Injection Is A Proton Pump Inhibitor (Ppi) Indicated For The: • Short-Term Treatment Of Gastroesophageal Reflux Disease (Gerd) With Erosive Esophagitis (Ee) In Adults And Pediatric Patients 1 Month To 17 Years Of Age, As An Alternative To Oral Therapy When Oral Esomeprazole Is Not Possible Or Appropriate. ( 1.1 ) • Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers Following Therapeutic Endoscopy For Acute Bleeding Gastric Or Duodenal Ulcers In Adults. ( 1.2 ) 1.1 Treatment Of Gastroesophageal Reflux Disease (Gerd) With Erosive Esophagitis (Ee) Esomeprazole Sodium For Injection Is Indicated For The Short-Term Treatment Of Gerd With Ee In Adults And Pediatric Patients 1 Month To 17 Years, Inclusively As An Alternative To Oral Therapy When Oral Esomeprazole Is Not Possible Or Appropriate. 1.2 Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers Following Therapeutic Endoscopy In Adults Esomeprazole Sodium For Injection Is Indicated For Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers Following Therapeutic Endoscopy For Acute Bleeding Gastric Or Duodenal Ulcers In Adults.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Esomeprazole Sodium ESOMEPRAZOLE SODIUM ZINC4693574

Comments