Orange Book product
DIAZEPAM 50MG/10ML (5MG/ML)
Orange Book ANDA 216422 · GALENICUM HEALTH SLU · Prescription
Key facts
| Proprietary name | DIAZEPAM |
|---|---|
| Active ingredients | DIAZEPAM |
| Strength | 50MG/10ML (5MG/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA216422 |
| Applicant holder | GALENICUM HEALTH SLU |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 19, 2025 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.