Orange Book product

FORMOTEROL FUMARATE 0.02MG/2ML

Orange Book ANDA 215053 · LUPIN INC · Prescription

Key facts

Proprietary name FORMOTEROL FUMARATE
Active ingredients FORMOTEROL FUMARATE
Strength 0.02MG/2ML
Dosage form SOLUTION
Route INHALATION
Application ANDA215053
Applicant holder LUPIN INC
Marketing status Prescription
Therapeutic equivalence (TE) code AN
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 22, 2022

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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