Drug application

GUANFACINE HYDROCHLORIDE (GUANFACINE HYDROCHLORIDE)

Drugs@FDA ANDA 200881 · ACTAVIS ELIZABETH

Key facts

Drug name GUANFACINE HYDROCHLORIDE
Active ingredients GUANFACINE HYDROCHLORIDE
Application type ANDA
Application number 200881
Company ACTAVIS ELIZABETH
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 1MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Oct 5, 2012

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 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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