Fluoxetine Hydrochloride

Treats Major Depressive Disorder. ANDA 76001, held by Teva Pharms USA. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 76001 (Fluoxetine Hydrochloride), held by Teva Pharms USA, was first approved by FDA on Jan 29, 2002, with 29 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2002
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Acute treatment of Panic Disorder, with or without agoraphobia. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Jan 29, 2002	Original application	Approved	None posted

Products

2 strengths and forms


Fluoxetine HydrochlorideEQ 10MG BASE · capsule;oral	Fluoxetine Hydrochloride	Rx
Fluoxetine HydrochlorideEQ 20MG BASE · capsule;oral	Fluoxetine Hydrochloride	Rx

All 30 submissions, including labeling and manufacturing supplements


Oct 24, 2024	Supplement 60Labeling · Standard review	Approved	None posted
Oct 24, 2024	Supplement 54Labeling · Standard review	Approved	None posted
Oct 24, 2024	Supplement 50Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 48Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 46Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 43Labeling · Standard review	Approved	None posted
Jan 10, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Jan 10, 2016	Supplement 30Labeling	Approved	None posted
Nov 17, 2014	Supplement 39Labeling · Standard review	Approved	None posted
Nov 17, 2014	Supplement 38Labeling · Standard review	Approved	None posted
Nov 17, 2014	Supplement 36Labeling · Standard review	Approved	None posted
Oct 17, 2014	Supplement 35Manufacturing	Approved	None posted
Aug 19, 2014	Supplement 37Manufacturing	Approved	None posted
Feb 28, 2012	Supplement 33Labeling	Approved	None posted
Feb 28, 2012	Supplement 32Labeling	Approved	None posted
May 19, 2010	Supplement 28Labeling	Approved	None posted
Sep 28, 2009	Supplement 25Labeling	Approved	None posted
Aug 18, 2008	Supplement 22Labeling	Approved	None posted
Aug 18, 2008	Supplement 20Labeling	Approved	None posted
Jan 16, 2008	Supplement 17Labeling	Approved	None posted
Jan 16, 2008	Supplement 15Labeling	Approved	None posted
Sep 28, 2007	Supplement 9Labeling	Approved	None posted
May 24, 2007	Supplement 14Labeling	Approved	None posted
Oct 5, 2006	Supplement 13Labeling	Approved	None posted
Mar 2, 2006	Supplement 5Labeling	Approved	None posted
Apr 22, 2005	Supplement 4Labeling	Approved	None posted
Apr 22, 2005	Supplement 3Labeling	Approved	None posted
Apr 22, 2005	Supplement 2Labeling	Approved	None posted
Nov 26, 2003	Supplement 1Labeling	Approved	None posted
Jan 29, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76001
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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