fluvoxamine maleate · Jazz Pharms · NDA 022033
Luvox Cr
Earliest generic entry, as listed · earliest of 2 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 220328, Appco · 022033-001Approved 30 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220768, Micro Labs · 022033-001Approved 23 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220447, Zydus Pharms · 022033-001Approved 21 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022033 · 001 · RLD · discontinued | capsule, extended release, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022033 · 002 · RLD · discontinued | capsule, extended release, oral | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |