fluoxetine hydrochloride · Eli Lilly And Co · NDA 018936, 020101, 020974
Prozac
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018936 · 001 · RLD · discontinued | capsule, oral | EQ 20MG BASE | open |
| 018936 · 003 · RLD · discontinued | capsule, oral | EQ 40MG BASE | open |
| 018936 · 004 · discontinued | capsule, oral | EQ 60MG BASE | open |
| 018936 · 006 · RLD · discontinued | capsule, oral | EQ 10MG BASE | open |
| 020101 · 001 · RLD · discontinued | solution, oral | EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020974 · 001 · RLD · discontinued | tablet, oral | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020974 · 002 · RLD · discontinued | tablet, oral | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |