Drug application

BUPRENORPHINE; NALOXONE (BUPRENORPHINE;NALOXONE)

Drugs@FDA ANDA 207087 · ACTAVIS LABS UT INC

Key facts

Drug name BUPRENORPHINE; NALOXONE
Active ingredients BUPRENORPHINE;NALOXONE
Application type ANDA
Application number 207087
Company ACTAVIS LABS UT INC
Dosage forms FILM, BUCCAL, SUBLINGUAL
Strength 12MG/3MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Nov 15, 2017

At a glance

  • 1–9 Submissions
  • None Label versions
  • None Products
  • None Therapeutic equivalents

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

Browse all Drugs@FDA applications