Drug application

PREGABALIN (PREGABALIN)

Drugs@FDA ANDA 209743 · AMNEAL PHARMS CO

Key facts

Drug name PREGABALIN
Active ingredients PREGABALIN
Application type ANDA
Application number 209743
Company AMNEAL PHARMS CO
Dosage forms CAPSULE, ORAL
Strength 25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 19, 2019

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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