Drug application

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 089647 · PHARM ASSOC

Key facts

Drug name PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Active ingredients CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 089647
Company PHARM ASSOC
Dosage forms SYRUP, ORAL
Strength 10MG/5ML;6.25MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Dec 22, 1988

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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