Drug application

DORAL (QUAZEPAM)

Drugs@FDA NDA 018708 · GALT PHARMS

Key facts

Drug name DORAL
Active ingredients QUAZEPAM
Application type NDA
Application number 018708
Company GALT PHARMS
Dosage forms TABLET, ORAL
Strength 15MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Dec 27, 1985

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes 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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