Drug application

CIALIS (TADALAFIL)

Drugs@FDA NDA 021368 · LILLY

Key facts

Drug name CIALIS
Active ingredients TADALAFIL
Application type NDA
Application number 021368
Company LILLY
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Prescription
TE codes AB1
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Nov 21, 2003

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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