Drug application

CERUMENEX (TROLAMINE POLYPEPTIDE OLEATE CONDENSATE)

Drugs@FDA NDA 011340 · PHARM RES ASSOC

Key facts

Drug name CERUMENEX
Active ingredients TROLAMINE POLYPEPTIDE OLEATE CONDENSATE
Application type NDA
Application number 011340
Company PHARM RES ASSOC
Dosage forms SOLUTION/DROPS, OTIC
Strength 10%
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jun 25, 1958

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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