Orange Book product

GENTAMICIN EQ 100MG BASE/100ML

Orange Book ANDA 062325 · INTERNATIONAL MEDICATION SYSTEMS LTD · Discontinued

Key facts

Proprietary name GENTAMICIN
Active ingredients GENTAMICIN SULFATE
Strength EQ 100MG BASE/100ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA062325
Applicant holder INTERNATIONAL MEDICATION SYSTEMS LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 23, 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)

Browse all Orange Book products