Application 208789
- Type
- ANDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50742-485 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-485 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |