Orange Book product

LORAZEPAM 2MG/ML

Orange Book ANDA 076150 · INTERNATIONAL MEDICATION SYSTEMS LTD · Prescription

Key facts

Proprietary name LORAZEPAM
Active ingredients LORAZEPAM
Strength 2MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA076150
Applicant holder INTERNATIONAL MEDICATION SYSTEMS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 15, 2004

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)

Browse all Orange Book products