Details for New Drug Application (NDA): 202599
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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 202599
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202599
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 202599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 202599 | ANDA | Eugia US LLC | 55150-126 | 55150-126-20 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-126-20) / 20 mL in 1 VIAL, MULTI-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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