loteprednol etabonate; tobramycin · Bausch And Lomb · NDA 050804
Zylet
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- First generic approved · ANDA 217597, Alembic · 050804-001Approved 10 Dec 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217597, Alembic · 050804-001Approved 10 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050804 · 001 · RLD | suspension/drops, ophthalmic | 0.5%;0.3% | open |