FdaApplication
ANDA 203631
Identifiers
- fda_app_no: ANDA203631
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS LLC |
| application_type | ANDA |
| approval_date | 2025-09-10 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SODIUM OXYBATE | SODIUM OXYBATE | 0.5GM/ML | SOLUTION;ORAL |
1 product