Orange Book product

NORCO 325MG;5MG

Orange Book ANDA 040099 · ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD · Discontinued

Key facts

Proprietary name NORCO
Active ingredients ACETAMINOPHEN, HYDROCODONE BITARTRATE
Strength 325MG;5MG
Dosage form TABLET
Route ORAL
Application ANDA040099
Applicant holder ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 25, 1997

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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