Details for New Drug Application (NDA): 078050
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NDA 078050 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Steriscience Speclts, Sun Pharm Inds (in), Wockhardt, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty-six suppliers. Additional details are available on the ONDANSETRON profile page.
The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078050
| Tradename: | ONDANSETRON |
| Applicant: | Sandoz |
| Ingredient: | ondansetron |
| Patents: | 0 |
Pharmacology for NDA: 078050
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078050
Suppliers and Packaging for NDA: 078050
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078050 | ANDA | Proficient Rx LP | 63187-002 | 63187-002-10 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-10) |
| ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 078050 | ANDA | Proficient Rx LP | 63187-002 | 63187-002-15 | 15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-002-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 4MG | ||||
| Approval Date: | Aug 13, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 8MG | ||||
| Approval Date: | Aug 13, 2007 | TE: | AB | RLD: | No | ||||
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