Details for New Drug Application (NDA): 091483
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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-two suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 091483
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091483
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 091483
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 091483 | ANDA | Major Pharmaceuticals | 0904-7073 | 0904-7073-93 | 30 CUP in 1 CARTON (0904-7073-93) / 5 mL in 1 CUP (0904-7073-41) |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 091483 | ANDA | AvPAK | 50268-647 | 50268-647-14 | 40 CUP, UNIT-DOSE in 1 TRAY (50268-647-14) / 5 mL in 1 CUP, UNIT-DOSE (50268-647-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Jan 31, 2011 | TE: | AA | RLD: | No |
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