Orange Book product

REVATIO EQ 20MG BASE

Orange Book NDA 021845 · VIATRIS SPECIALTY LLC · Prescription

Key facts

Proprietary name REVATIO
Active ingredients SILDENAFIL CITRATE
Strength EQ 20MG BASE
Dosage form TABLET
Route ORAL
Application NDA021845
Applicant holder VIATRIS SPECIALTY LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jun 3, 2005

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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