Application 206995
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRESSA | GEFITINIB | TABLET;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-0482 | IRESSA | Gefitinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0482 | IRESSA | Gefitinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0482 | IRESSA | Gefitinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67431 | SUPPL | 2021-05-07 |
| 67419 | SUPPL | 2021-05-06 |
| 55313 | SUPPL | 2018-08-24 |
| 55273 | SUPPL | 2018-08-23 |
| 23029 | ORIG | 2016-07-28 |
| 10605 | ORIG | 2015-07-15 |
| 19953 | ORIG | 2015-07-13 |