Orange Book product

NALOXONE HYDROCHLORIDE 1MG/ML

Orange Book ANDA 072115 · INTERNATIONAL MEDICATION SYSTEMS LTD · Discontinued

Key facts

Proprietary name NALOXONE HYDROCHLORIDE
Active ingredients NALOXONE HYDROCHLORIDE
Strength 1MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA072115
Applicant holder INTERNATIONAL MEDICATION SYSTEMS LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 27, 1988

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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