Drug application

ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN, CODEINE PHOSPHATE)

Drugs@FDA ANDA 040098 · DAVA PHARMS INC

Key facts

Drug name ACETAMINOPHEN AND CODEINE PHOSPHATE
Active ingredients ACETAMINOPHEN, CODEINE PHOSPHATE
Application type ANDA
Application number 040098
Company DAVA PHARMS INC
Dosage forms SOLUTION, ORAL
Strength 120MG/5ML;12MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Sep 20, 1996

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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