fluphenazine hydrochloride · Schering · NDA 012034, 012419, 016008
Permitil
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 |
|---|---|---|---|
| 012034 · 001 · discontinued | tablet, oral | 0.25MG | open |
| 012034 · 004 · discontinued | tablet, oral | 2.5MG | open |
| 012034 · 005 · discontinued | tablet, oral | 5MG | open |
| 012034 · 006 · discontinued | tablet, oral | 10MG | open |
| 012419 · 004 · discontinued | tablet, extended release, oral | 1MG | open |
| 016008 · 001 · discontinued | concentrate, oral | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |