Skip to content
Application 217684
- Type
- NDA
- Sponsor
- PYROS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIGAFYDE | VIGABATRIN | SOLUTION;ORAL | 100MG/ML | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85616 | SUPPL | 2026-04-01 |
| 83293 | SUPPL | 2025-09-05 |
| 83292 | SUPPL | 2025-09-05 |
| 83291 | SUPPL | 2025-09-05 |
| 83280 | SUPPL | 2025-09-04 |
| 83279 | SUPPL | 2025-09-04 |
| 82202 | ORIG | 2025-05-19 |
| 79620 | SUPPL | 2024-09-16 |
| 78818 | ORIG | 2024-06-18 |
| 78817 | ORIG | 2024-06-18 |