Orange Book product

METHADONE HYDROCHLORIDE 40MG

Orange Book ANDA 074081 · ROXANE LABORATORIES INC · Discontinued

Key facts

Proprietary name METHADONE HYDROCHLORIDE
Active ingredients METHADONE HYDROCHLORIDE
Strength 40MG
Dosage form TABLET
Route ORAL
Application ANDA074081
Applicant holder ROXANE LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 28, 1995

At a glance

  • None 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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