Orange Book product

DURADYNE DHC 500MG;5MG

Orange Book ANDA 087809 · FOREST PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name DURADYNE DHC
Active ingredients ACETAMINOPHEN, HYDROCODONE BITARTRATE
Strength 500MG;5MG
Dosage form TABLET
Route ORAL
Application ANDA087809
Applicant holder FOREST PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 17, 1983

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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