Drug application

QUINAGLUTE (QUINIDINE GLUCONATE)

Drugs@FDA NDA 016647 · BAYER HLTHCARE

Key facts

Drug name QUINAGLUTE
Active ingredients QUINIDINE GLUCONATE
Application type NDA
Application number 016647
Company BAYER HLTHCARE
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Dec 8, 1969

At a glance

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