Orange Book product

ALENDRONATE SODIUM EQ 70MG BASE/75ML

Orange Book ANDA 214523 · PRECISION DOSE INC · Prescription

Key facts

Proprietary name ALENDRONATE SODIUM
Active ingredients ALENDRONATE SODIUM
Strength EQ 70MG BASE/75ML
Dosage form SOLUTION
Route ORAL
Application ANDA214523
Applicant holder PRECISION DOSE INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 2, 2026

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