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 | Ondansetron Oral Solution, Taro Pharma, Tentative Approval | Ondansetron Hydrochloride Tablets, Mylan Pharma, Tentative Approval | Ondansetron Orally Disintegrating Tablets, Kali Labs, Approval | Zofran (ondansetron hydrochloride) Injection, GlaxoSmithKline, Labeling Revision | Zofran (ondansetron hydrochloride) Premixed Injection, GlaxoSmithKline, Labeling Revision | Zofran (ondansetron) Tablets, GlaxoSmithKline, Labeling Revision | Zofran ODT (ondansetron) Orally Disintegrating Tablets, GlaxoSmithKline, Labeling Revision | Zofran (ondansetron hydrochloride) Oral Solution, GlaxoSmithKline, Labeling Revision | Ondansetron Hydrochloride Tablets, Kali Labs, Tentative Approval | Ondansetron Injection, Teva, Tentative Approval | Ondansetron Hydrochloride Tablets, Teva Pharma, Tentative Approval | Ondansetron Injection, Amer. Pharma Partners, Tentative Approval | Ondansetron Injection, PharmaForce, Tentative Approval | Ondansetron HCI Injection, Taro Pharma, Tentative Approval | Ondansetron Injection, Sun Pharma, Tentative Approval | Ondansetron Injection, Hikma Farma, Tentative Approval | Ondansetron Injection, Baxter Healthcare, Tentative Approval | Ondansetron Injection, Baxter Healthcare, Tentative Approval | Ondansetron Injection, Baxter Healthcare, Tentative Approval | Ondansetron Orally Disintegrating Tablets, Sun Pharma, Tentative Approval | Ondansetron Injection, Hospira Inc., Tentative Approval | Ondansetron Hydrochloride Tablets, Pliva, Tentative Approval | Ondansetron Orally Disintegrating Tablets, Sun Pharma, Tentative Approval | Ondansetron Oral Solution, Roxane Labs, Tentative Approval | Ondansetron Injection, Pharmaforce, Tentative Approval | ZOFRAN (ondansetron hydrochloride) Injection, GlaxoSmithKline, Labeling Revision | ZOFRAN (ondansetron hydrochloride) Injection Premixed, GlaxoSmithKline, Labeling Revision | ZOFRAN (ondansetron hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | ZOFRAN (ondansetron hydrochloride) Oral Solution, GlaxoSmithKline, Labeling Revision | ZOFRAN ODT (ondansetron hydrochloride) Orally Disintegrating Tablets, GlaxoSmithKline, Labeling Revision | Ondansetron and 5% Dextrose Injectable, SICOR Pharmaceuticals, Tentative Approval | Ondansetron Hydrochloride Tablets, Glenmark Pharma, Tentative Approval | Ondansetron Injection, Teva Pharma, Approval | Ondansetron and Dextrose Injection, Sicor Pharma, Approval | Ondansetron Orally Disintegrating Tablets, Kali Labs, Tentative Approval | Ondansetron Injection, Apotex Inc., Tentative Approval | Ondansetron Injection, Pliva Hrvatska, Tentative Approval | Ondansetron Injection, Apotex Inc., Tentative Approval | Ondansetron Oral Solution, Apotex Inc., Tentative Approval | Ondansetron Hydrochloride Tablets, Apotex Inc., Tentative Approval | Ondansetron Injection, Sun Pharma, Approval | Ondansetron Injection, Bedford Labs, Approval | Ondansetron Injection, Abraxis Pharma, Approval | Ondansetron Injection, Hikma Farmaceutica, Approval | Ondansetron Injection, Baxter Healthcare Corp., Approval | Ondansetron Injection, Pharmaforce Inc., Approval | Ondansetron Injection, Mayne Pharma, Approval | Ondansetron Injection, Wockhardt Inc., Approval | Ondansetron Injection, Pliva Inc., Approval | Ondansetron Injection, Apotex Corp., Approval | Ondansetron Oral Solution, Roxane Labs, Approval | Ondansetron Orally Disintegrating Tablets, Kali Labs, Approval | Ondansetron Injection, Hospira Inc., Approval | Ondansetron Hydrochloride Tablets, Dr. Reddy’s Labs, Approval | Ondansetron Injection, Baxter Healthcare, Approval | Ondansetron Hydrochloride Tablets, Kali Labs, Tentative Approval | Ondansetron Hydrochloride Tablets, Pliva, Tentative Approval | Ondansetron Injection, Hospira Inc., Approval | Ondansetron and Dextrose Injection, Hospira Inc., Approval | Ondansetron Hydrochloride Tablets, Glenmark Pharma, Tentative Approval | Ondansetron Orally Disintegrating Tablets, Mylan Pharma, Tentative Approval | Ondansetron and Dextrose Injection, Mayne Pharma, Approval | Ondansetron Injection, Spectrum Pharma, Approval | Ondansetron Hydrochloride Tablets, Sandoz Inc., Tentative Approval | Ondansetron Orally Disintegrating Tablets, KV Pharma, Tentative Approval | Ondansetron Injection, Apotex, Manufacturing Revision | Ondansetron Hydrochloride Injection, Apotex Inc., Manufacturing Revision | Ondansetron Hydrochloride Tablets, Pliva Hrvatska, Approval | Ondansetron Hydrochloride Tablets, Sun Pharma, Approval | Ondansetron Hydrochloride Tablets, Sandoz Inc., Approval | Ondansetron Hydrochloride Tablets, Kali Labs, Approval | Ondansetron Hydrochloride Tablets, Mylan Pharma, Approval | Ondansetron Hydrochloride Tablets, Teva Pharma, Approval | Ondansetron Hydrochloride Tablets, Natco Pharma, Approval | Ondansetron Hydrochloride Tablets, Glenmark Pharma, Approval
| Ondansetron Hydrochloride Oral Solution, Apotex Inc., Approval | Ondansetron Hydrochloride Orally Disintegrating Tablets, KV Pharma, Approval | Ondansetron Hydrochloride Orally Disintegrating Tablets, Glenmark Pharma, Approval
| Ondansetron Hydrochloride Orally Disintegrating Tablets, Barr Labs, Approval | Ondansetron Hydrochloride Injection, Sandoz Inc., Approval | Ondansetron Hydrochloride Tablets, Aurobindo Pharma, Approval | Ondansetron Orally Disintegrating Tablets, Sun Pharma, Approval | Ondansetron Orally Disintegrating Tablets, Sandoz Inc., Approval | Ondansetron Hydrochloride Tablets, West-ward Pharma, Approval | Ondansetron Oral Solution, Aurobindo Pharma, Approval
| Ondansetron Oral Solution, Taro Pharma, Approval | Ondansetron Hydrochloride and Dextrose in Plastic Container Injection, Claris Lifesciences, Approval | Ondansetron Injection, Taro Pharma, Approval | Ondansetron Injection, Akorn-Strides, Approval | Ondansetron Injection, Luitpold Pharmaceuticals, Inc., Approval