Details for New Drug Application (NDA): 078244
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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 078244
Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Steriscience |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078244
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078244
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 078244 | ANDA | Steriscience Specialties Private Limited | 82449-200 | 82449-200-03 | 25 VIAL, SINGLE-DOSE in 1 CARTON (82449-200-03) / 2 mL in 1 VIAL, SINGLE-DOSE (82449-200-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Apr 23, 2008 | TE: | RLD: | No |
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