Drug application

LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)

Drugs@FDA ANDA 200908 · PH HEALTH

Key facts

Drug name LABETALOL HYDROCHLORIDE
Active ingredients LABETALOL HYDROCHLORIDE
Application type ANDA
Application number 200908
Company PH HEALTH
Dosage forms TABLET, ORAL
Strength 100MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Jul 10, 2012

At a glance

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