Orange Book product

AMIKACIN SULFATE EQ 50MG BASE/ML

Orange Book ANDA 064045 · MEITHEAL PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name AMIKACIN SULFATE
Active ingredients AMIKACIN SULFATE
Strength EQ 50MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA064045
Applicant holder MEITHEAL PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 28, 1993

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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