Details for New Drug Application (NDA): 078776
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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 078776
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078776
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 078776
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 078776 | ANDA | NorthStar Rx LLC | 16714-671 | 16714-671-02 | 1 BOTTLE, PLASTIC in 1 CARTON (16714-671-02) / 50 mL in 1 BOTTLE, PLASTIC |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 078776 | ANDA | Aurobindo Pharma Limited | 65862-208 | 65862-208-04 | 1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Nov 28, 2007 | TE: | AA | RLD: | No |
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