Drug application

PROZAC (FLUOXETINE HYDROCHLORIDE)

Drugs@FDA NDA 018936 · ELI LILLY AND CO

Key facts

Drug name PROZAC
Active ingredients FLUOXETINE HYDROCHLORIDE
Application type NDA
Application number 018936
Company ELI LILLY AND CO
Dosage forms CAPSULE, ORAL
Strength EQ 20MG BASE
Marketing status Discontinued
TE codes AB1
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Dec 29, 1987

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

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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