hydrocortisone; neomycin sulfate · Bayer Pharms · NDA 050237, 050238
Neo-Cort-Dome
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050237 · 005 · discontinued | cream, topical | 1%;EQ 3.5MG BASE/GM | open |
| 050237 · 006 · discontinued | cream, topical | 0.5%;EQ 3.5MG BASE/GM | open |
| 050238 · 001 · discontinued | suspension/drops, otic | 2%;1%;EQ 0.35% BASE | open |