Orange Book product · Brand (NDA)
IRESSA
GEFITINIB
At a glance
Jul 13, 2015
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
GEFITINIB
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 206995
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2003IRESSABrand (NDA)
NDA 021399 · ASTRAZENECA
- 2025GEFITINIBGeneric (ANDA)
ANDA 211826 · CIPLA
- 2023GEFITINIBGeneric (ANDA)
ANDA 212827 · NATCO
- 2023GEFITINIBGeneric (ANDA)
ANDA 208913 · ACTAVIS LABS FL INC
- 2023GEFITINIBGeneric (ANDA)
ANDA 211591 · QILU PHARM HAINAN
- 2022GEFITINIBGeneric (ANDA)
ANDA 209532 · APOTEX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
