Orange Book product

CLOMIPRAMINE HYDROCHLORIDE 50MG

Orange Book ANDA 211364 · LEADING PHARMA LLC · Prescription

Key facts

Proprietary name CLOMIPRAMINE HYDROCHLORIDE
Active ingredients CLOMIPRAMINE HYDROCHLORIDE
Strength 50MG
Dosage form CAPSULE
Route ORAL
Application ANDA211364
Applicant holder LEADING PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 7, 2020

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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