Drug application

LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)

Drugs@FDA ANDA 075223 · APOTHECON

Key facts

Drug name LABETALOL HYDROCHLORIDE
Active ingredients LABETALOL HYDROCHLORIDE
Application type ANDA
Application number 075223
Company APOTHECON
Dosage forms TABLET, ORAL
Strength 100MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Nov 23, 1998

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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