Drug application

OTOBIOTIC (HYDROCORTISONE, POLYMYXIN B SULFATE)

Drugs@FDA ANDA 062302 · SCHERING

Key facts

Drug name OTOBIOTIC
Active ingredients HYDROCORTISONE, POLYMYXIN B SULFATE
Application type ANDA
Application number 062302
Company SCHERING
Dosage forms SOLUTION/DROPS, OTIC
Strength 5MG/ML;EQ 10,000 UNITS BASE/ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Dec 1, 1981

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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