Drug application

PROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 040650 · PHARM ASSOC

Key facts

Drug name PROMETHAZINE WITH CODEINE
Active ingredients CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 040650
Company PHARM ASSOC
Dosage forms SYRUP, ORAL
Strength 10MG/5ML;6.25MG/5ML
Marketing status Discontinued
TE codes AA
Reference listed drug No
Latest submission status date Jan 31, 2006

At a glance

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