Drug application

PCE (ERYTHROMYCIN)

Drugs@FDA NDA 050611 · AZURITY

Key facts

Drug name PCE
Active ingredients ERYTHROMYCIN
Application type NDA
Application number 050611
Company AZURITY
Dosage forms TABLET, COATED PARTICLES, ORAL
Strength 333MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Sep 9, 1986

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 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 · Source date:

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