FDA Orange Book
Generic for Iressa
Iressa contains gefitinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Iressa is gefitinib. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Iressa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 250MG | Discontinued | None | 3 | AB |
NDA 206995, 021399, held by ASTRAZENECA UK LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gefitinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| QILU PHARMACEUTICAL HAINAN CO LTD | 211591 | AB (A-rated, therapeutically equivalent) | February 13, 2023 | 250MG, 250MG |
| ACTAVIS LABORATORIES FL INC | 208913 | AB (A-rated, therapeutically equivalent) | April 26, 2023 | 250MG, 250MG |
| NATCO PHARMA LTD | 212827 | AB (A-rated, therapeutically equivalent) | May 31, 2023 | 250MG, 250MG |
Iressa NDC codes
Questions
Is there a generic for Iressa?
Yes. The generic name for Iressa is gefitinib. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Iressa?
The active ingredient in Iressa is gefitinib, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.