Orange Book product

NEOSPORIN G.U. IRRIGANT EQ 40MG BASE/ML;200,000 UNITS/ML

Orange Book ANDA 060707 · MONARCH PHARMACEUTICALS LLC · Discontinued

Key facts

Proprietary name NEOSPORIN G.U. IRRIGANT
Active ingredients NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Strength EQ 40MG BASE/ML;200,000 UNITS/ML
Dosage form SOLUTION
Route IRRIGATION
Application ANDA060707
Applicant holder MONARCH PHARMACEUTICALS LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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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