Details for New Drug Application (NDA): 078287
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NDA 078287 describes ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Onesource Specialty, Sandoz, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, and Wockhardt Bio Ag, and is included in twenty NDAs. It is available from eleven suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE profile page.
The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 078287
| Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | ondansetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078287
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 078287 | ANDA | Baxter Healthcare Corporation | 36000-012 | 36000-012-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (36000-012-25) / 2 mL in 1 VIAL, SINGLE-DOSE |
| ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 078287 | ANDA | Cardinal Health 107, LLC | 55154-4453 | 55154-4453-5 | 5 VIAL in 1 BAG (55154-4453-5) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Feb 22, 2013 | TE: | AP | RLD: | No | ||||
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