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Ondansetron hydrochlorideis the generic ingredient in six branded drugs marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hikma Pharms, Hospira, Lannett Co Inc, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), Teva, Wockhardt, Am Regent, Emcure Pharms Ltd, Sun Pharm Inds Ltd, Taro Pharms Ireland, Novartis, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.
There are twenty-eight drug master file entries for ondansetron hydrochloride. Sixty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ondansetron hydrochloride
|Drug Master File Entries:||28|
|Finished Product Suppliers / Packagers:||65|
|Raw Ingredient (Bulk) Api Vendors:||73|
|Formulation / Manufacturing:||see details|
|What excipients (inactive ingredients) are in ondansetron hydrochloride?||ondansetron hydrochloride excipients list|
|DailyMed Link:||ondansetron hydrochloride at DailyMed|
Recent Clinical Trials for ondansetron hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Tel-Aviv Sourasky Medical Center||N/A|
|CHU de Quebec-Universite Laval||Phase 3|
|Laval University||Phase 3|
Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ondansetron hydrochloride
|Drug Class||Serotonin-3 Receptor Antagonist |
|Mechanism of Action||Serotonin 3 Receptor Antagonists |
Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE
|ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER||INJECTABLE;INJECTION||ondansetron hydrochloride||020403|
|ZOFRAN PRESERVATIVE FREE||INJECTABLE;INJECTION||ondansetron hydrochloride||020007|
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