Details for New Drug Application (NDA): 076960
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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-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 076960
Tradename: | ONDANSETRON HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | ondansetron hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076960
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Suppliers and Packaging for NDA: 076960
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 076960 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0064 | 0054-0064-47 | 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS |
ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 076960 | ANDA | Precision Dose Inc. | 68094-763 | 68094-763-62 | 3 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 4MG BASE/5ML | ||||
Approval Date: | Dec 26, 2006 | TE: | AA | RLD: | No |
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