Vybrique (sildenafil citrate)

New dosage form

Region: 🇺🇸 US
Active substance: sildenafil citrate
Company: Ibsa
Status: Approved
FDA approval: Tue 16 Dec 2025
Designations: New dosage form
Application: NDA210858
Official record: www.accessdata.fda.gov

Regulatory milestones

Tue 16 Dec 2025🇺🇸 FDA approval

FDA approves Vybrique (sildenafil citrate): new dosage form

Ibsa; NDA210858; New dosage form; film · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.