Drug application

PRIMAQUINE (PRIMAQUINE PHOSPHATE)

Drugs@FDA NDA 008316 · SANOFI AVENTIS US

Key facts

Drug name PRIMAQUINE
Active ingredients PRIMAQUINE PHOSPHATE
Application type NDA
Application number 008316
Company SANOFI AVENTIS US
Dosage forms TABLET, ORAL
Strength EQ 15MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Jan 23, 1952

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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 · Source date:

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