Orange Book product

ADCIRCA 20MG

Orange Book NDA 022332 · ELI LILLY CO · Prescription

Key facts

Proprietary name ADCIRCA
Active ingredients TADALAFIL
Strength 20MG
Dosage form TABLET
Route ORAL
Application NDA022332
Applicant holder ELI LILLY CO
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date May 22, 2009

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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