Drug application

SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)

Drugs@FDA ANDA 075725 · RISING

Key facts

Drug name SOTALOL HYDROCHLORIDE
Active ingredients SOTALOL HYDROCHLORIDE
Application type ANDA
Application number 075725
Company RISING
Dosage forms TABLET, ORAL
Strength 80MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Dec 19, 2000

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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