Orange Book product

AMIKACIN SULFATE EQ 250MG BASE/ML

Orange Book ANDA 204040 · AVET LIFESCIENCES LTD · Prescription

Key facts

Proprietary name AMIKACIN SULFATE
Active ingredients AMIKACIN SULFATE
Strength EQ 250MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA204040
Applicant holder AVET LIFESCIENCES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Dec 12, 2013

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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