Details for New Drug Application (NDA): 076974
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NDA 076974 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by 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, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from sixty-five suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.
The generic ingredient in ONDANSETRON HYDROCHLORIDE 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 HYDROCHLORIDE 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 076974
| Tradename: | ONDANSETRON HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ondansetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076974
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 076974
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076974 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1377 | 51662-1377-1 | 20 mL in 1 VIAL (51662-1377-1) |
| ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076974 | ANDA | Fresenius Kabi USA, LLC | 63323-374 | 63323-374-20 | 1 VIAL in 1 BOX (63323-374-20) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Dec 26, 2006 | TE: | AP | RLD: | No | ||||
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