Orange Book product

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 500MG;50MG;40MG

Orange Book ANDA 040883 · MIRROR PHARMACEUTICALS LLC · Discontinued

Key facts

Proprietary name BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Active ingredients ACETAMINOPHEN, BUTALBITAL, CAFFEINE
Strength 500MG;50MG;40MG
Dosage form TABLET
Route ORAL
Application ANDA040883
Applicant holder MIRROR PHARMACEUTICALS LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 23, 2008

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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