Drug application

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN, CODEINE PHOSPHATE)

Drugs@FDA ANDA 085861 · ACTAVIS MID ATLANTIC

Key facts

Drug name ACETAMINOPHEN AND CODEINE PHOSPHATE
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Application type ANDA
Application number 085861
Company ACTAVIS MID ATLANTIC
Dosage forms SOLUTION, ORAL
Strength 120MG/5ML;12MG/5ML
Marketing status Discontinued
Reference listed drug Yes
Latest submission status date Jun 20, 1978

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

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 · Source date:

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