Application Nr Approved Date Route Status External Links
ANDA206846 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ondansetron Injection Usp Is A 5-Ht 3 Receptor Antagonist Indicated For The Prevention Of:: Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy. ( 1.1 ) Postoperative Nausea And/or Vomiting. ( 1.2 ) 1.1 Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy Ondansetron Injection Usp Is Indicated For The Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy, Including High-Dose Cisplatin. Ondansetron Injection Usp Is Approved For Patients Aged 6 Months And Older. 1.2 Prevention Of Postoperative Nausea And/or Vomiting Ondansetron Injection Usp Is Indicated For The Prevention Of Postoperative Nausea And/or Vomiting. As With Other Antiemetics, Routine Prophylaxis Is Not Recommended For Patients In Whom There Is Little Expectation That Nausea And/or Vomiting Will Occur Postoperatively. In Patients In Whom Nausea And/or Vomiting Must Be Avoided Postoperatively, Ondansetron Injection Usp Is Recommended Even When The Incidence Of Postoperative Nausea And/or Vomiting Is Low. For Patients Who Do Not Receive Prophylactic Ondansetron Injection Usp And Experience Nausea And/or Vomiting Postoperatively, Ondansetron Injection Usp May Be Given To Prevent Further Episodes. Ondansetron Injection Usp Is Approved For Patients Aged 1 Month And Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ondansetron ONDANSETRON ZINC4448

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