Application 021399
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRESSA | GEFITINIB | TABLET;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021399-001 | IRESSA | GEFITINIB | 250MG | TABLET / ORAL | 2003-05-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021399-001 | IRESSA | 250MG | TABLET / ORAL | 2003-05-05 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021399-001 | IRESSA | 250MG | TABLET / ORAL | 2003-05-05 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021399-001 | IRESSA | 250MG | TABLET / ORAL | 2003-05-05 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021399-001 | IRESSA | 250MG | TABLET / ORAL | 2003-05-05 | 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 |
|---|---|---|---|---|---|---|
| Gefitinib | GEFITINIB | Natco Pharma USA LLC | 1a3c0ce7-06a1-4e04-9106-14ddb2a866a5 | 2026-03-10 | Warnings, Adverse reactions | GEFITINIB |
| Gefitinib | GEFITINIB | Ingenus Pharmaceuticals, LLC | 6402435f-9f6a-4f02-91a2-6267d783fa78 | 2023-12-28 | Warnings, Adverse reactions | GEFITINIB |
| IRESSA | GEFITINIB | AstraZeneca Pharmaceuticals LP | 827d60e8-7e07-41b7-c28b-49ef1c4a5a41 | 2023-02-28 | Warnings, Adverse reactions | IRESSA GEFITINIB |
| Gefitinib | GEFITINIB | Qilu Pharmaceutical Co., Ltd. | 0afc12dd-12f8-4def-9027-f38412a862b9 | 2023-02-22 | Warnings, Adverse reactions | GEFITINIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.