fluphenazine hydrochloride · Apothecon · NDA 011751, 012145
Prolixin
Earliest generic entry, as listed · earliest of 5 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
- Generic approved · ANDA 218769, Hetero Labs Ltd Iii · 011751-001Approved 18 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 011751 · 001 · RLD · discontinued | tablet, oral | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011751 · 002 · RLD · discontinued | tablet, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011751 · 003 · RLD · discontinued | tablet, oral | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011751 · 004 · RLD · discontinued | tablet, oral | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011751 · 005 · discontinued | injectable, injection | 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 012145 · 003 · RLD · discontinued | elixir, oral | 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |