Orange Book product
DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that…
Orange Book NDA 020648 · BAUSCH HEALTH US LLC · Discontinued
Key facts
| Proprietary name | DIASTAT |
|---|---|
| Active ingredients | DIAZEPAM |
| Strength | 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | GEL |
| Route | RECTAL |
| Application | NDA020648 |
| Applicant holder | BAUSCH HEALTH US LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jul 29, 1997 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.