Orange Book product

FLUOXETINE HYDROCHLORIDE EQ 90MG BASE

Orange Book ANDA 078572 · DR REDDYS LABORATORIES LTD · Prescription

Key facts

Proprietary name FLUOXETINE HYDROCHLORIDE
Active ingredients FLUOXETINE HYDROCHLORIDE
Strength EQ 90MG BASE
Dosage form CAPSULE, DELAYED REL PELLETS
Route ORAL
Application ANDA078572
Applicant holder DR REDDYS LABORATORIES LTD
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Mar 22, 2010

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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