Orange Book product

HYDROCODONE BITARTRATE AND ACETAMINOPHEN 750MG;7.5MG

Orange Book ANDA 040822 · RANBAXY LABORATORIES LTD · Discontinued

Key facts

Proprietary name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredients ACETAMINOPHEN, HYDROCODONE BITARTRATE
Strength 750MG;7.5MG
Dosage form TABLET
Route ORAL
Application ANDA040822
Applicant holder RANBAXY LABORATORIES LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 16, 2007

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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