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Application 220313
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | LIQUID;ORAL | 1.1GM/ML | No | No |
| 002 | GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | LIQUID | 1.1G/1ML | No | No |
| 003 | GLYCEROL PHENYLBUTYRATE | GLYCEROL PHENYLBUTYRATE | LIQUID | 450ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84995 | ORIG | 2026-02-11 |