Application Nr Approved Date Route Status External Links
ANDA078539 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ondansetron 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 Tablets Are Also Indicated For The Prevention Of Postoperative Nausea And/or Vomiting. Ondansetron 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 Hydrochloride ONDANSETRON HYDROCHLORIDE ZINC4448

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