Orange Book product
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML
Orange Book ANDA 076931 · HIKMA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | BUPRENORPHINE HYDROCHLORIDE |
|---|---|
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE |
| Strength | EQ 0.3MG BASE/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA076931 |
| Applicant holder | HIKMA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 2, 2005 |
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.