Orange Book product · Brand (NDA)
CEDAX
CEFTIBUTEN DIHYDRATE
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EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 050686
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.
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.
