approval · primary record
SILDENAFIL CITRATE
2 approval events · latest 2025-12-16
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-12-16 |
| Approval events | 2 |
| Brand | VYBRIQUE |
| Sponsor | IBSA |
| Route | ORAL |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-12-16 | FDA | NDA | VYBRIQUE | IBSA | ORAL |
| 2024-12-16 | FDA | NDA | REVATIO | VIATRIS | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:29.440Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:sildenafil-citrate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Sildenafil Citrate · compound