Orange Book product

MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE

Orange Book ANDA 076938 · DR REDDYS LABORATORIES LTD · Prescription

Key facts

Proprietary name MOXIFLOXACIN HYDROCHLORIDE
Active ingredients MOXIFLOXACIN HYDROCHLORIDE
Strength EQ 400MG BASE
Dosage form TABLET
Route ORAL
Application ANDA076938
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Mar 4, 2014

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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