Details for New Drug Application (NDA): 202253
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NDA 202253 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, Sandoz, Steriscience Speclts, Sun Pharm Inds Ltd, Taro Pharms Ireland, Teva, and Wockhardt, 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 are twenty-eight drug master file entries for this compound. Sixty-six 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 are twenty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 202253
| Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ondansetron hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202253
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 202253
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 202253 | ANDA | Fresenius Kabi USA, LLC | 76045-103 | 76045-103-20 | 24 BLISTER PACK in 1 CARTON (76045-103-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-103-00) / 2 mL in 1 SYRINGE, GLASS |
| ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 202253 | ANDA | Fresenius Kabi USA, LLC | 76045-216 | 76045-216-20 | 24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Jul 19, 2013 | TE: | AP | RLD: | No | ||||
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