Drug application

TREPROSTINIL (TREPROSTINIL)

Drugs@FDA ANDA 208906 · ACTAVIS LABS

Key facts

Drug name TREPROSTINIL
Active ingredients TREPROSTINIL
Application type ANDA
Application number 208906
Company ACTAVIS LABS
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 0.125MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Apr 3, 2023

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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