Drug application

ACETYLCYSTEINE (ACETYLCYSTEINE)

Drugs@FDA ANDA 072324 · ROXANE

Key facts

Drug name ACETYLCYSTEINE
Active ingredients ACETYLCYSTEINE
Application type ANDA
Application number 072324
Company ROXANE
Dosage forms SOLUTION, INHALATION, ORAL
Strength 20%
Marketing status Discontinued
Reference listed drug No
Latest submission status date Apr 30, 1992

At a glance

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

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