Drug application

STATROL (NEOMYCIN SULFATE, POLYMYXIN B SULFATE)

Drugs@FDA NDA 050344 · ALCON

Key facts

Drug name STATROL
Active ingredients NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Application type NDA
Application number 050344
Company ALCON
Dosage forms OINTMENT, OPHTHALMIC
Strength EQ 3.5MG BASE/GM;10,000 UNITS/GM
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Mar 12, 1974

At a glance

  • 1–9 Submissions
  • 10–99 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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