Orange Book product

ZOLEDRONIC ACID EQ 4MG BASE/5ML

Orange Book ANDA 202571 · CHARTWELL RX SCIENCES LLC · Prescription

Key facts

Proprietary name ZOLEDRONIC ACID
Active ingredients ZOLEDRONIC ACID
Strength EQ 4MG BASE/5ML
Dosage form INJECTABLE
Route INTRAVENOUS
Application ANDA202571
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 7, 2013

At a glance

  • 10–99 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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