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Application 210858
- Type
- NDA
- Sponsor
- IBSA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VYBRIQUE | SILDENAFIL CITRATE | FILM;ORAL | EQ 25MG BASE | Yes | No |
| 002 | VYBRIQUE | SILDENAFIL CITRATE | FILM;ORAL | EQ 50MG BASE | Yes | No |
| 003 | VYBRIQUE | SILDENAFIL CITRATE | FILM;ORAL | EQ 75MG BASE | Yes | No |
| 004 | VYBRIQUE | SILDENAFIL CITRATE | FILM;ORAL | EQ 100MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84726 | ORIG | 2026-01-09 |
| 84433 | ORIG | 2025-12-17 |