Orange Book product · Brand (NDA)
ZYFLO CR
ZILEUTON
At a glance
May 30, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2007
19 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ZILEUTON
Strength
600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022052
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 2019ZILEUTONGeneric (ANDA)
ANDA 211972 · LUPIN
- 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.
