Orange Book product
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE
Orange Book ANDA 203326 · HIKMA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
|---|---|
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
| Strength | EQ 8MG BASE;EQ 2MG BASE |
| Dosage form | TABLET |
| Route | SUBLINGUAL |
| Application | ANDA203326 |
| Applicant holder | HIKMA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jun 27, 2014 |
At a glance
- 10–99 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.