dexamethasone; neomycin sulfate; polymyxin b sulfate · Harrow Eye · NDA 050023, 050065
Maxitrol
Earliest generic entry, as listed · earliest of 2 marketed strengths
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050023 · 002 · RLD | suspension/drops, ophthalmic | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | open |
| 050065 · 002 · RLD | ointment, ophthalmic | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | open |