Orange Book product

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 1.2MG BASE/ML

Orange Book ANDA 062373 · BAXTER HEALTHCARE CORP · Prescription

Key facts

Proprietary name GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Active ingredients GENTAMICIN SULFATE
Strength EQ 1.2MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA062373
Applicant holder BAXTER HEALTHCARE CORP
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 7, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 10–99 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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