Application Nr Approved Date Route Status External Links
ANDA076960 2006-12-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy, Including Cisplatin ≥50 Mg/m2. Prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy. 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. 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, Ondansetron Oral Solution, Usp Is Recommended Even Where The Incidence Of Postoperative Nausea And/or Vomiting Is Low.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Saccharin Sodium SACCHARIN SODIUM Molecular
4. Sodium Benzoate SODIUM BENZOATE Molecular
5. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular

Active Ingredients ( 1 Total)

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