Details for New Drug Application (NDA): 078287
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The generic ingredient in ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-four 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 |
Formulation / Manufacturing: | see details |
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 in 1 CARTON (36000-012-25) / 2 mL in 1 VIAL |
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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