Application 208109
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-942 | Palonosetron | Palonosetron | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-942 | Palonosetron | Palonosetron | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56644 | SUPPL | 2019-07-15 |
| 50501 | ORIG | 2018-12-20 |
| 56667 | SUPPL | 2018-12-07 |
| 55854 | ORIG | 2018-10-09 |
| 50469 | ORIG | 2017-11-22 |