Details for New Drug Application (NDA): 077541
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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-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 077541
Tradename: | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE |
Applicant: | Hikma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077541
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 077541
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 077541 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6078 | 0641-6078-25 | 25 VIAL in 1 CARTON (0641-6078-25) / 2 mL in 1 VIAL (0641-6078-01) |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 077541 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6080 | 0641-6080-25 | 25 VIAL in 1 CARTON (0641-6080-25) / 2 mL in 1 VIAL (0641-6080-01) |
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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