FdaApplication
NDA 213378
Identifiers
- fda_app_no: NDA213378
Properties
| Property | Value |
|---|---|
| applicant_name | ALKERMES INC |
| application_type | NDA |
| approval_date | 2021-05-28 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | 20MG;EQ 10MG BASE | TABLET;ORAL |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | 10MG;EQ 10MG BASE | TABLET;ORAL |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | 5MG;EQ 10MG BASE | TABLET;ORAL |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | 15MG;EQ 10MG BASE | TABLET;ORAL |
4 products