FDA Orange Book
Generic for Zylet
Zylet contains loteprednol etabonate and tobramycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Zylet is loteprednol etabonate and tobramycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zylet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 0.5%;0.3% | Marketed (Rx) | AB | 1 | AB |
NDA 050804, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic loteprednol etabonate and tobramycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 217597 | AB (A-rated, therapeutically equivalent) | December 10, 2025 | 0.5%;0.3% |
Zylet NDC codes
Questions
Is there a generic for Zylet?
Yes. The generic name for Zylet is loteprednol etabonate and tobramycin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Zylet?
The active ingredient in Zylet is loteprednol etabonate and tobramycin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.