Drug application

HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 200737 · ALKEM LABS LTD

Key facts

Drug name HYDRALAZINE HYDROCHLORIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE
Application type ANDA
Application number 200737
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status Prescription
TE codes AA
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Dec 7, 2012

At a glance

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