terbinafine hydrochloride · Karo Hlthcare · NDA 020192, 020539, 020749, 020846, 020980, 022071
Lamisil
Earliest generic entry, as listed
Open now
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 |
|---|---|---|---|
| 020192 · 001 · discontinued | cream, topical | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020539 · 001 · RLD · discontinued | tablet, oral | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020749 · 001 · discontinued | solution, topical | 1% | open |
| 020846 · 001 · discontinued | gel, topical | 1% | open |
| 020980 · 001 · RLD | cream, topical | 1% | open |
| 022071 · 001 · RLD · discontinued | granule, oral | EQ 125MG BASE/PACKET | open |
| 022071 · 002 · RLD · discontinued | granule, oral | EQ 187.5MG BASE/PACKET | open |