FdaApplication
NDA 204242
Identifiers
- fda_app_no: NDA204242
Properties
| Property | Value |
|---|---|
| applicant_name | EDENBRIDGE PHARMACEUTICALS LLC DBA DEXCEL PHARMA USA |
| application_type | NDA |
| approval_date | 2013-07-03 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET;SUBLINGUAL |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 1.4MG BASE;EQ 0.36MG BASE | TABLET;SUBLINGUAL |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET;SUBLINGUAL |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 5.7MG BASE;EQ 1.4MG BASE | TABLET;SUBLINGUAL |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8.6MG BASE;EQ 2.1MG BASE | TABLET;SUBLINGUAL |
| ZUBSOLV | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 11.4MG BASE;EQ 2.9MG BASE | TABLET;SUBLINGUAL |
6 products