Drug application

VARENICLINE TARTRATE (VARENICLINE TARTRATE)

Drugs@FDA ANDA 217283 · NE RX PHARMA

Key facts

Drug name VARENICLINE TARTRATE
Active ingredients VARENICLINE TARTRATE
Application type ANDA
Application number 217283
Company NE RX PHARMA
Dosage forms TABLET, ORAL
Strength EQ 0.5MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 6, 2024

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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