granisetron hydrochloride · Roche · NDA 020239, 020305, 021238
Kytril
Earliest generic entry, as listed · earliest of 7 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 |
|---|---|---|---|
| 020239 · 001 · RLD · discontinued | injectable, injection | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020239 · 002 · RLD · discontinued | injectable, injection | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020239 · 003 · RLD · discontinued | injectable, injection | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020239 · 004 · RLD · discontinued | injectable, injection | EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020305 · 001 · RLD · discontinued | tablet, oral | EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** | open |
| 020305 · 002 · RLD · discontinued | tablet, oral | EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** | open |
| 021238 · 001 · RLD · discontinued | solution, oral | EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |