Details for New Drug Application (NDA): 076972
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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 076972
Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076972
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 076972
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076972 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1366 | 51662-1366-1 | 2 mL in 1 VIAL (51662-1366-1) |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076972 | ANDA | Fresenius Kabi USA, LLC | 63323-373 | 63323-373-02 | 25 VIAL in 1 TRAY (63323-373-02) / 2 mL in 1 VIAL (63323-373-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
Approval Date: | Dec 26, 2006 | TE: | AP | RLD: | No |
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