Orange Book product · Brand (NDA)
IRESSA
GEFITINIB
At a glance
May 05, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 05, 2003
23 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
GEFITINIB
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021399
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2015IRESSABrand (NDA)
NDA 206995 · 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.
