Drug application

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN, BUTALBITAL, CAFFEINE and 1 more)

Drugs@FDA ANDA 076528 · ABLE

Key facts

Drug name BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Active ingredients ACETAMINOPHEN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE
Application type ANDA
Application number 076528
Company ABLE
Dosage forms CAPSULE, ORAL
Strength 325MG;50MG;40MG;30MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Aug 21, 2003

At a glance

  • 1–9 Submissions
  • 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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