Orange Book product · Brand (NDA)
TOBRADEX
DEXAMETHASONE; TOBRAMYCIN
At a glance
Aug 18, 1988
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 18, 1988
38 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXAMETHASONE; TOBRAMYCIN
Strength
0.1%;0.3%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
NDA 050592
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.
- 2009TOBRADEX STBrand (NDA)
NDA 050818 · HARROW EYE
- 1988TOBRADEXBrand (NDA)
NDA 050616 · NOVARTIS
- 2022TOBRAMYCIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 212715 · PADAGIS US
- 2021TOBRAMYCIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 212991 · AMNEAL
- 1999TOBRAMYCIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 064134 · BAUSCH AND LOMB INC
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.
