Orange Book product

NEOMYCIN AND POLYMYXIN B SULFATE EQ 40MG BASE/ML;200,000 UNITS/ML

Orange Book ANDA 065106 · XGEN PHARMACEUTICALS DJB INC · Prescription

Key facts

Proprietary name NEOMYCIN AND POLYMYXIN B SULFATE
Active ingredients NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Strength EQ 40MG BASE/ML;200,000 UNITS/ML
Dosage form SOLUTION
Route IRRIGATION
Application ANDA065106
Applicant holder XGEN PHARMACEUTICALS DJB INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jan 31, 2006

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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