Drug application

AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE)

Drugs@FDA ANDA 085968 · SANDOZ

Key facts

Drug name AMITRIPTYLINE HYDROCHLORIDE
Active ingredients AMITRIPTYLINE HYDROCHLORIDE
Application type ANDA
Application number 085968
Company SANDOZ
Dosage forms TABLET, ORAL
Strength 50MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission status date Nov 29, 1977

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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