Drug application

AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE)

Drugs@FDA ANDA 214548 · UNICHEM

Key facts

Drug name AMITRIPTYLINE HYDROCHLORIDE
Active ingredients AMITRIPTYLINE HYDROCHLORIDE
Application type ANDA
Application number 214548
Company UNICHEM
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 19, 2021

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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