Application 203050
- Type
- NDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | No | No |
| 002 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82016 | SUPPL | 2025-04-28 |
| 81957 | SUPPL | 2025-04-24 |
| 79139 | SUPPL | 2024-07-22 |
| 79110 | SUPPL | 2024-07-18 |
| 46134 | ORIG | 2016-12-13 |
| 40255 | ORIG | 2016-03-03 |
| 32364 | ORIG | 2016-03-03 |
| 32363 | ORIG | 2012-11-06 |