diazepam · Bausch · NDA 020648
Diastat
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
- 25 Oct 2026Generic approved · 020648-00114 Nov 2025
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020648 · 001 · RLD | gel, rectal | 2.5MG/0.5ML (5MG/ML) | open |
| 020648 · 002 · RLD · discontinued | gel, rectal | 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020648 · 003 · RLD · discontinued | gel, rectal | 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020648 · 004 · RLD · discontinued | gel, rectal | 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020648 · 005 · RLD · discontinued | gel, rectal | 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |