FdaApplication
ANDA 205960
Identifiers
- fda_app_no: ANDA205960
Properties
| Property | Value |
|---|---|
| applicant_name | BRECKENRIDGE PHARMACEUTICAL INC |
| application_type | ANDA |
| approval_date | 2020-12-10 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 5MG BASE | TABLET;SUBLINGUAL |
| ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 2.5MG BASE | TABLET;SUBLINGUAL |
| ASENAPINE MALEATE | ASENAPINE MALEATE | EQ 10MG BASE | TABLET;SUBLINGUAL |
3 products