FdaApplication
NDA 022410
Identifiers
- fda_app_no: NDA022410
Properties
| Property | Value |
|---|---|
| applicant_name | INDIVIOR INC |
| application_type | NDA |
| approval_date | 2010-08-30 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 4MG BASE;EQ 1MG BASE | FILM;BUCCAL, SUBLINGUAL |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 12MG BASE;EQ 3MG BASE | FILM;BUCCAL, SUBLINGUAL |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | FILM;BUCCAL, SUBLINGUAL |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | FILM;BUCCAL, SUBLINGUAL |
4 products