Orange Book product

HYDROCODONE BITARTRATE AND ACETAMINOPHEN 750MG;7.5MG

Orange Book ANDA 040469 · ABLE LABORATORIES INC · Discontinued

Key facts

Proprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredients ACETAMINOPHEN, HYDROCODONE BITARTRATE
Strength 750MG;7.5MG
Dosage form TABLET
Route ORAL
Application ANDA040469
Applicant holder ABLE LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 25, 2002

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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