Orange Book product

CITALOPRAM HYDROBROMIDE EQ 10MG BASE/5ML

Orange Book ANDA 201450 · HETERO LABS LTD UNIT III · Prescription

Key facts

Proprietary name CITALOPRAM HYDROBROMIDE
Active ingredients CITALOPRAM HYDROBROMIDE
Strength EQ 10MG BASE/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA201450
Applicant holder HETERO LABS LTD UNIT III
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 15, 2015

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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