Orange Book product

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER EQ 0.8MG BASE/ML

Orange Book ANDA 062814 · B BRAUN MEDICAL INC · Discontinued

Key facts

Proprietary name GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Active ingredients GENTAMICIN SULFATE
Strength EQ 0.8MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA062814
Applicant holder B BRAUN MEDICAL INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 28, 1987

At a glance

  • None 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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