Application 203050
- Type
- NDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203050-001 | POSFREA | PALONOSETRON HYDROCHLORIDE | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2016-03-01 | |
| N203050-002 | POSFREA | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-03-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N203050-001 | POSFREA | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2016-03-01 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N203050-002 | POSFREA | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2016-03-01 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| posfrea | PALONOSETRON | Avyxa Pharma, LLC | 13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7 | 2025-04-29 | Warnings, Adverse reactions | 203050 NDA203050 |