Drug application

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 040675 · HIKMA PHARMS

Key facts

Drug name PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
Active ingredients PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
Application type ANDA
Application number 040675
Company HIKMA PHARMS
Dosage forms SYRUP, ORAL
Strength 5MG/5ML;6.25MG/5ML
Marketing status Discontinued
TE codes AA
Reference listed drug No
Latest submission status date Dec 23, 2014

At a glance

  • 1–9 Submissions
  • 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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