hydrocortisone sodium phosphate · Merck · NDA 008228, 008506, 009018, 012052
Hydrocortone
Earliest generic entry, as listed
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 008228 · 001 · discontinued | injectable, injection | 25MG/ML | open |
| 008228 · 004 · discontinued | injectable, injection | 50MG/ML | open |
| 008506 · 007 · discontinued | tablet, oral | 10MG | open |
| 008506 · 011 · discontinued | tablet, oral | 20MG | open |
| 009018 · 003 · discontinued | ointment, ophthalmic, otic | 1.5% | open |
| 012052 · 001 · RLD · discontinued | injectable, injection | EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |