Orange Book product · Brand (NDA)
ZYLET
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Brand (NDA)NDA 050804TE ABRX BAUSCH AND LOMB
At a glance
Dec 14, 2004
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2004
21 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Strength
0.5%;0.3%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
NDA 050804
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
