FDA Orange Book · active-ingredient family
Loteprednol etabonate; tobramycin
Loteprednol etabonate; tobramycin is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYLET · NDA 050804
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYLETRLD | BAUSCH AND LOMB | NDA 050804 | AB | Dec 14, 2004 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTEPREDNOL ETABONATE AND TOBRAMYCIN | ALEMBIC | ANDA 217597 | AB | Dec 10, 2025 |
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.
Loteprednol etabonate; tobramycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
