Application Nr Approved Date Route Status External Links
NDA022524 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zuplenz Is A 5-Ht3 Receptor Antagonist Indicated For: Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy. ( 1.1 ) Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy. ( 1.2 ) Prevention Of Nausea And Vomiting Associated With Radiotherapy In Patients Receiving Total Body Irradiation, Single High-Dose Fraction To Abdomen, Or Daily Fractions To The Abdomen. ( 1.3 ) Prevention Of Postoperative Nausea And/or Vomiting. ( 1.4 ) 1.1 Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy Zuplenz (Ondansetron) Oral Soluble Film Is Indicated For The Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy, Including Cisplatin ≥50 Mg/m 2 [See Clinical Studies, (14.1) ] . 1.2 Prevention Of Nausea And Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy Zuplenz Is Indicated For The Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy [See Clinical Studies (14.1) ] . 1.3 Prevention Of Nausea And Vomiting Associated With Radiotherapy Zuplenz Is Indicated For The Prevention Of 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 [See Clinical Studies (14.2) ] . 1.4 Prevention Of Postoperative Nausea And/or Vomiting Zuplenz 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 Where Nausea And/or Vomiting Must Be Avoided Postoperatively, Zuplenz Is Recommended Even Where The Incidence Of Postoperative Nausea And/or Vomiting Is Low [See Clinical Studies (14.3) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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