Drug application

FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 078143 · CHARTWELL RX

Key facts

Drug name FLUOXETINE HYDROCHLORIDE
Active ingredients FLUOXETINE HYDROCHLORIDE
Application type ANDA
Application number 078143
Company CHARTWELL RX
Dosage forms CAPSULE, ORAL
Strength EQ 10MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jan 16, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None 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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