prednisolone sodium phosphate · Merck · NDA 011028, 011583
Hydeltrasol
Earliest generic entry, as listed · earliest of 2 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 011028 · 001 · discontinued | ointment, ophthalmic, otic | EQ 0.25% PHOSPHATE | open |
| 011583 · 002 · discontinued | injectable, injection | EQ 20MG PHOSPHATE/ML | open |