Drug application

GUANFACINE HYDROCHLORIDE (GUANFACINE HYDROCHLORIDE)

Drugs@FDA ANDA 202578 · PHARMOBEDIENT

Key facts

Drug name GUANFACINE HYDROCHLORIDE
Active ingredients GUANFACINE HYDROCHLORIDE
Application type ANDA
Application number 202578
Company PHARMOBEDIENT
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 1MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jun 2, 2015

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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