Application 202951
- Type
- ANDA
- Sponsor
- EMCURE PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | 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 |
|---|---|---|---|---|---|
| 23155-356 | Palonosetron Hydrochloride | Palonosetron Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 70860-785 | Palonosetron Hydrochloride | palonosetron hydrochloride | Athenex Pharmaceutical Division, LLC. | ANDA | Current |