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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210858
Company: IBSA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYBRIQUE SILDENAFIL CITRATE EQ 25MG BASE FILM;ORAL Prescription None Yes No
VYBRIQUE SILDENAFIL CITRATE EQ 50MG BASE FILM;ORAL Prescription None Yes No
VYBRIQUE SILDENAFIL CITRATE EQ 75MG BASE FILM;ORAL Prescription None Yes No
VYBRIQUE SILDENAFIL CITRATE EQ 100MG BASE FILM;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/16/2025 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210858s000lbl.pdf httpS://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210858Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/16/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210858s000lbl.pdf
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