Orange Book product · Generic (ANDA)
LOTEPREDNOL ETABONATE AND TOBRAMYCIN
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Generic (ANDA)ANDA 217597TE ABRX ALEMBIC
At a glance
Dec 10, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 10, 2025
6 mo ago
Today
Exclusivity ends · CGT
FDA marketing exclusivity
Jul 14, 2026
in 25 d
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Strength
0.5%;0.3%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 217597
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LOTEPREDNOL ETABONATE; TOBRAMYCIN
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Jul 14, 2026
in 25 d
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.
