Application Nr Approved Date Route Status External Links
ANDA090469 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ondansetron Orally Disintegrating Tablets Are Indicated For The Prevention Of Nausea And Vomiting Associated With: • Highly Emetogenic Cancer Chemotherapy, Including Cisplatin Greater Than Or Equal To 50 Mg/m 2 • Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy • Radiotherapy In Patients Receiving Either Total Body Irradiation, Single High-Dose Fraction To The Abdomen, Or Daily Fractions To The Abdomen Ondansetron Orally Disintegrating Tablets Also Indicated For The Prevention Of Postoperative Nausea And/or Vomiting. Ondansetron Orally Disintegrating Tablets Are A 5-Ht 3 Receptor Antagonist Indicated For The Prevention Of: • Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy, Including Cisplatin Greater Than Or Equal To 50 Mg/m 2 (1) • Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy (1) • Nausea And Vomiting Associated With Radiotherapy In Patients Receiving Either Total Body Irradiation, Single High-Dose Fraction To The Abdomen, Or Daily Fractions To The Abdomen (1) • Postoperative Nausea And/or Vomiting (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments