Orange Book product

AZITHROMYCIN EQ 200MG BASE/5ML

Orange Book ANDA 211147 · ZYDUS LIFESCIENCES GLOBAL FZE · Prescription

Key facts

Proprietary name AZITHROMYCIN
Active ingredients AZITHROMYCIN
Strength EQ 200MG BASE/5ML
Dosage form FOR SUSPENSION
Route ORAL
Application ANDA211147
Applicant holder ZYDUS LIFESCIENCES GLOBAL FZE
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 31, 2018

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)

Browse all Orange Book products