Orange Book product

ESCITALOPRAM OXALATE EQ 5MG BASE/5ML

Orange Book ANDA 202754 · MACLEODS PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name ESCITALOPRAM OXALATE
Active ingredients ESCITALOPRAM OXALATE
Strength EQ 5MG BASE/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA202754
Applicant holder MACLEODS PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 31, 2016

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)

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