Drug application
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE)
Drugs@FDA NDA 022410 · INDIVIOR
Key facts
| Drug name | SUBOXONE |
|---|---|
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 022410 |
| Company | INDIVIOR |
| Dosage forms | FILM, BUCCAL, SUBLINGUAL |
| Strength | EQ 2MG BASE;EQ 0.5MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Aug 30, 2010 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- 10–99 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: