hydroxyzine hydrochloride · Pfizer · NDA 011111, 011459, 011795
Vistaril
Earliest generic entry, as listed · earliest of 6 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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 011111 · 001 · RLD · discontinued | injectable, injection | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011111 · 002 · RLD · discontinued | injectable, injection | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011459 · 002 · RLD · discontinued | capsule, oral | EQ 25MG HYDROCHLORIDE | open |
| 011459 · 004 · RLD · discontinued | capsule, oral | EQ 50MG HYDROCHLORIDE | open |
| 011459 · 006 · RLD · discontinued | capsule, oral | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011795 · 001 · RLD · discontinued | suspension, oral | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |