Application 210064
- Type
- NDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 150MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210064-001 | FOSAPREPITANT DIMEGLUMINE | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER / INTRAVENOUS | 2019-09-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210064-001 | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER / INTRAVENOUS | 2019-09-05 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N210064-001 | FOSAPREPITANT DIMEGLUMINE | EQ 150MG BASE/VIAL | POWDER / INTRAVENOUS | 2019-09-05 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fosaprepitant | FOSAPREPITANT | Actavis Pharma, Inc. | 9dbd4c29-d894-4839-9b22-a2f65c8c8ad1 | 2022-06-30 | Warnings, Adverse reactions | 210064 NDA210064 0591-4385 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.