FdaApplication
ANDA 219727
Identifiers
- fda_app_no: ANDA219727
Properties
| Property | Value |
|---|---|
| applicant_name | ASCENT PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2025-12-15 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 8MG BASE;EQ 2MG BASE | TABLET;SUBLINGUAL |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | EQ 2MG BASE;EQ 0.5MG BASE | TABLET;SUBLINGUAL |
2 products