| Product NDC: | 0310-0482 |
| Proprietary Name: | IRESSA |
| Non Proprietary Name: | Gefitinib |
| Active Ingredient(s): | 250 mg/1 & nbsp; Gefitinib |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0310-0482 |
| Labeler Name: | AstraZeneca Pharmaceuticals LP |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021399 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20030513 |
| Package NDC: | 0310-0482-30 |
| Package Description: | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) |
| NDC Code | 0310-0482-30 |
| Proprietary Name | IRESSA |
| Package Description | 30 TABLET, COATED in 1 BOTTLE (0310-0482-30) |
| Product NDC | 0310-0482 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Gefitinib |
| Dosage Form Name | TABLET, COATED |
| Route Name | ORAL |
| Start Marketing Date | 20030513 |
| Marketing Category Name | NDA |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | GEFITINIB |
| Strength Number | 250 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |