Drug application

HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)

Drugs@FDA ANDA 040010 · HIKMA PHARMS

Key facts

Drug name HYDROXYZINE HYDROCHLORIDE
Active ingredients HYDROXYZINE HYDROCHLORIDE
Application type ANDA
Application number 040010
Company HIKMA PHARMS
Dosage forms SYRUP, ORAL
Strength 10MG/5ML
Marketing status Discontinued
TE codes AA
Reference listed drug No
Latest submission status date Oct 28, 1994

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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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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