Fluoxetine Hydrochloride

ANDA 75865, held by Ivax Sub Teva Pharms. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 75865 (Fluoxetine Hydrochloride), held by Ivax Sub Teva Pharms, was first approved by FDA on Feb 28, 2002, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2002
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 28, 2002	Original application	Approved	None posted

Products

2 strengths and forms


Fluoxetine HydrochlorideEQ 10MG BASE · tablet;oral	Fluoxetine Hydrochloride	Discontinued
Fluoxetine HydrochlorideEQ 40MG BASE · tablet;oral	Fluoxetine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 17, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Nov 17, 2005	Supplement 11Labeling	Approved	None posted
Aug 30, 2004	Supplement 4Labeling	Approved	None posted
Feb 28, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75865
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters