Details for New Drug Application (NDA): 202600
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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-seven suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 202600
Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Eugia Pharma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202600
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 202600
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 202600 | ANDA | Eugia US LLC | 55150-125 | 55150-125-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Dec 21, 2012 | TE: | RLD: | No |
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