Orange Book product

IBANDRONATE SODIUM EQ 150MG BASE

Orange Book ANDA 204502 · AUROBINDO PHARMA LTD · Prescription

Key facts

Proprietary name IBANDRONATE SODIUM
Active ingredients IBANDRONATE SODIUM
Strength EQ 150MG BASE
Dosage form TABLET
Route ORAL
Application ANDA204502
Applicant holder AUROBINDO PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 11, 2016

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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