Drug application

AMANTADINE HYDROCHLORIDE (AMANTADINE HYDROCHLORIDE)

Drugs@FDA ANDA 070589 · UPSHER SMITH LABS

Key facts

Drug name AMANTADINE HYDROCHLORIDE
Active ingredients AMANTADINE HYDROCHLORIDE
Application type ANDA
Application number 070589
Company UPSHER SMITH LABS
Dosage forms CAPSULE, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jan 7, 1987

At a glance

  • 1–9 Submissions
  • 10–99 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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