Application 205870
- Type
- ANDA
- Sponsor
- SAGENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 25021-788 | palonosetron hydrochloride | palonosetron hydrochloride | Sagent Pharmaceuticals | ANDA | Current |