Drug application

BUTALBITAL, ASPIRIN AND CAFFEINE (ASPIRIN, BUTALBITAL, CAFFEINE)

Drugs@FDA ANDA 086162 · HIKMA INTL PHARMS

Key facts

Drug name BUTALBITAL, ASPIRIN AND CAFFEINE
Active ingredients ASPIRIN, BUTALBITAL, CAFFEINE
Application type ANDA
Application number 086162
Company HIKMA INTL PHARMS
Dosage forms TABLET, ORAL
Strength 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission status date Jun 5, 1979

At a glance

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