Orange Book product · Generic (ANDA)
ZILEUTON
ZILEUTON
At a glance
Nov 05, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2019
6 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ZILEUTON
Strength
600MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 211972
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ZILEUTON
- 2007ZYFLO CRBrand (NDA)
NDA 022052 · CHIESI
- 1996ZYFLOBrand (NDA)
NDA 020471 · CHIESI
- 2022ZILEUTONGeneric (ANDA)
ANDA 215742 · ANNORA PHARMA
- 2022ZILEUTONGeneric (ANDA)
ANDA 211043 · TEVA PHARMS USA
- 2020ZILEUTONGeneric (ANDA)
ANDA 211390 · AIZANT
- 2019ZILEUTONGeneric (ANDA)
ANDA 212670 · STRIDES PHARMA INTL
- 2017ZILEUTONGeneric (ANDA)
ANDA 204929 · RISING
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.
