Details for New Drug Application (NDA): 022233
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The generic ingredient in ALOXI is palonosetron hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
Summary for 022233
| Tradename: | ALOXI |
| Applicant: | Helsinn Hlthcare |
| Ingredient: | palonosetron hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 22, 2008 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 022233
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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