FdaApplication
ANDA 218473
Identifiers
- fda_app_no: ANDA218473
Properties
| Property | Value |
|---|---|
| applicant_name | SPECGX LLC |
| application_type | ANDA |
| approval_date | 2025-12-10 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;SUBLINGUAL |
| BUPRENORPHINE HYDROCHLORIDE | BUPRENORPHINE HYDROCHLORIDE | EQ 8MG BASE | TABLET;SUBLINGUAL |
2 products