prochlorperazine maleate · Glaxosmithkline · NDA 010571, 010742, 011000, 011127, 011188, 011276, 021019
Compazine
Earliest generic entry, as listed · earliest of 8 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 · 15
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 010571 · 001 · RLD · discontinued | tablet, oral | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 010571 · 002 · RLD · discontinued | tablet, oral | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 010571 · 003 · RLD · discontinued | tablet, oral | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 010742 · 002 · RLD · discontinued | injectable, injection | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011000 · 001 · discontinued | capsule, extended release, oral | EQ 10MG BASE | open |
| 011000 · 002 · discontinued | capsule, extended release, oral | EQ 15MG BASE | open |
| 011000 · 003 · discontinued | capsule, extended release, oral | EQ 30MG BASE | open |
| 011000 · 004 · discontinued | capsule, extended release, oral | EQ 75MG BASE | open |
| 011127 · 001 · RLD · discontinued | suppository, rectal | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011127 · 002 · RLD · discontinued | suppository, rectal | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011127 · 003 · RLD · discontinued | suppository, rectal | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011188 · 001 · discontinued | syrup, oral | EQ 5MG BASE/5ML | open |
| 011276 · 001 · RLD · discontinued | concentrate, oral | EQ 10MG BASE/ML | open |
| 021019 · 001 · discontinued | capsule, extended release, oral | EQ 10MG BASE | open |
| 021019 · 002 · discontinued | capsule, extended release, oral | EQ 15MG BASE | open |