Drug application

HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)

Drugs@FDA ANDA 040805 · HETERO LABS LTD III

Key facts

Drug name HYDROXYZINE HYDROCHLORIDE
Active ingredients HYDROXYZINE HYDROCHLORIDE
Application type ANDA
Application number 040805
Company HETERO LABS LTD III
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 29, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No 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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