Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   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 | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com