Orange Book product

MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML

Orange Book ANDA 076144 · INTERNATIONAL MEDICATED SYSTEMS LTD · Discontinued

Key facts

Proprietary name MIDAZOLAM HYDROCHLORIDE
Active ingredients MIDAZOLAM HYDROCHLORIDE
Strength EQ 1MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA076144
Applicant holder INTERNATIONAL MEDICATED SYSTEMS LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 26, 2005

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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