Details for New Drug Application (NDA): 078257
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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 078257
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Steriscience Speclts |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078257
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078257
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 078257 | ANDA | Steriscience Specialties Private Limited | 82449-201 | 82449-201-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (82449-201-01) / 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: | Apr 23, 2008 | TE: | RLD: | No |
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