Orange Book product

GENTAMICIN SULFATE EQ 1.6MG BASE/ML

Orange Book ANDA 062413 · ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV · Discontinued

Key facts

Proprietary name GENTAMICIN SULFATE
Active ingredients GENTAMICIN SULFATE
Strength EQ 1.6MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA062413
Applicant holder ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 11, 1983

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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