Drug application
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE)
Drugs@FDA ANDA 212756 · DIFGEN PHARMS
Key facts
| Drug name | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE |
|---|---|
| Active ingredients | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 212756 |
| Company | DIFGEN PHARMS |
| Dosage forms | FILM, BUCCAL, SUBLINGUAL |
| Strength | EQ 8MG BASE;EQ 2MG BASE |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Jun 2, 2022 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- No FDA letters on file
- No 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: