Application 022233
- Type
- NDA
- Sponsor
- HELSINN HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALOXI | PALONOSETRON HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69639-104 | ALOXI | palonosetron hydrochloride | Helsinn Therapeutics (U.S.), Inc. | NDA | Current |