Application 207963
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9513 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | West-Ward Pharmaceuticals Corp | NDA | Current |