Orange Book product · Generic (ANDA)
GEFITINIB
GEFITINIB
Generic (ANDA)ANDA 209532DISCN APOTEX
At a glance
Sep 23, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 23, 2022
3 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
GEFITINIB
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 209532
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GEFITINIB
- 2015IRESSABrand (NDA)
NDA 206995 · ASTRAZENECA
- 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
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.
