Orange Book product

FOSAMAX EQ 70MG BASE

Orange Book NDA 020560 · ORGANON LLC A SUB OF ORGANON AND CO · Prescription

Key facts

Proprietary name FOSAMAX
Active ingredients ALENDRONATE SODIUM
Strength EQ 70MG BASE
Dosage form TABLET
Route ORAL
Application NDA020560
Applicant holder ORGANON LLC A SUB OF ORGANON AND CO
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Oct 20, 2000

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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