Drug application

FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE)

Drugs@FDA ANDA 076990 · SUN PHARM INDS LTD

Key facts

Drug name FLUOXETINE HYDROCHLORIDE
Active ingredients FLUOXETINE HYDROCHLORIDE
Application type ANDA
Application number 076990
Company SUN PHARM INDS LTD
Dosage forms CAPSULE, ORAL
Strength EQ 40MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Dec 13, 2004

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None 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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