Orange Book product

IMIPRAMINE HYDROCHLORIDE 50MG

Orange Book ANDA 040903 · LEADING PHARMA LLC · Prescription

Key facts

Proprietary name IMIPRAMINE HYDROCHLORIDE
Active ingredients IMIPRAMINE HYDROCHLORIDE
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA040903
Applicant holder LEADING PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Oct 24, 2012

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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