Application 206802
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206802-001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE / INTRAVENOUS | AP | 2018-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206802-001 | AP |
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 | A206802-001 | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE / INTRAVENOUS | AP | 2018-09-19 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A206802-001 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| Palonosetron | PALONOSETRON | Fresenius Kabi USA, LLC | b93fae8e-2b76-421e-95bc-ba08c211a7ea | 2021-01-11 | Warnings, Adverse reactions | 63323-673 |
| PALONOSETRON | PALONOSETRON | Fresenius Kabi USA, LLC | 9132366b-b808-46c9-b167-c1900bc116b3 | 2020-12-29 | Warnings, Adverse reactions | 206802 ANDA206802 63323-673 |