Orange Book product · Brand (NDA)
CEDAX
CEFTIBUTEN DIHYDRATE
Brand (NDA)NDA 050685DISCN BURKE THERAP
At a glance
Dec 20, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 1995
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFTIBUTEN DIHYDRATE
Strength
EQ 400MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 050685
Product number
002
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.
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.
