FDA Approval Activities for this Drug…

Zofran & Zofran ODT (ondansetron) Tablets & Orally Disintegrating Tablets, GlaxoSmithKline NDA 20-103/S-21 & 20-781/S-03 1/31/03 2/12/03 Zofran (ondansetron) Tablets, Glaxo Wellcome NDA 20-103/S-018 20-605/S-005 20-718/S-002 12/13/00 2/20/01 2/20/01 Zofran (ondansetron) Tablets Glaxo Wellcome NDA 20-103/SE1-015 8/27/99 7/3/00 Zofran Indication: For the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin. Zofran ODT (odansetron) Orally Disintegrating Tablets Glaxo Wellcome NDA 20-781 1/27/99 1/27/99 1/27/99 5/23/01 Zofran indication: For prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of postoperative nausea and vomiting. Ondansetron Injection, Mayne Pharma Inc., Ondansetron Injection, Bedford Laboratories | Zofran (ondansetron hydrochloride) Tablets, GlaxoSmithKline, Control Supplement | Zofran (ondansetron hydrochloride) Injection, GlaxoSmithKline, Patient Population Altered

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