Orange Book product

ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML

Orange Book ANDA 218429 · SABA ILAC SANAYI VE TICARET AS · Prescription

Key facts

Proprietary name ARFORMOTEROL TARTRATE
Active ingredients ARFORMOTEROL TARTRATE
Strength EQ 0.015MG BASE/2ML
Dosage form SOLUTION
Route INHALATION
Application ANDA218429
Applicant holder SABA ILAC SANAYI VE TICARET AS
Marketing status Prescription
Therapeutic equivalence (TE) code AN
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 25, 2025

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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