FdaApplication
ANDA 220313
Identifiers
- fda_app_no: ANDA220313
Properties
| Property | Value |
|---|---|
| applicant_name | AUROBINDO PHARMA LTD |
| application_type | ANDA |
| approval_date | 2026-04-15 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1GM/ML | LIQUID;ORAL |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 450ML | LIQUID |
| GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | 1.1G/1ML | LIQUID |
3 products