Application Nr Approved Date Route Status External Links
ANDA076930 2007-06-25 Oral RX 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 (9 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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