FdaApplication
NDA 214755
Identifiers
- fda_app_no: NDA214755
Properties
| Property | Value |
|---|---|
| applicant_name | ALKERMES INC |
| application_type | NDA |
| approval_date | 2023-05-01 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LUMRYZ | SODIUM OXYBATE | 4.5GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE;ORAL |
| LUMRYZ | SODIUM OXYBATE | 6GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE;ORAL |
| LUMRYZ | SODIUM OXYBATE | 7.5GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE;ORAL |
| LUMRYZ | SODIUM OXYBATE | 9GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE;ORAL |
4 products