Drug application

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (ACETAMINOPHEN, BUTALBITAL, CAFFEINE)

Drugs@FDA ANDA 088616 · ACTAVIS LABS UT INC

Key facts

Drug name BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Active ingredients ACETAMINOPHEN, BUTALBITAL, CAFFEINE
Application type ANDA
Application number 088616
Company ACTAVIS LABS UT INC
Dosage forms TABLET, ORAL
Strength 325MG;50MG;40MG
Marketing status Prescription
TE codes AA
Reference listed drug Yes
Latest submission status date Nov 9, 1984

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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