Details for New Drug Application (NDA): 079224
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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 079224
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Gland Pharma Ltd |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 079224
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 079224
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 079224 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-547 | 23155-547-41 | 10 VIAL in 1 CARTON (23155-547-41) / 2 mL in 1 VIAL (23155-547-31) |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 079224 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-547 | 23155-547-42 | 25 VIAL in 1 CARTON (23155-547-42) / 2 mL in 1 VIAL (23155-547-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Sep 25, 2009 | TE: | AP | RLD: | No |
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