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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 Visit Betterchem's Drug Index for FDA's latest approval information.   Find other drugs… A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | USActives.com | Pharma Job Search | Pharma Company News © 2011 FindingHealthOnline™